Contract Laboratory .com analytical chemistry, pharmaceutical, toxicology, clinical research, pharmacology, bioanalytical, sterility, pyrogen, medical devices, cosmetics, food, nutritional, preclinical, biomechanical, biotechnology, pharmacokinetic testing laboratories for all your US FDA required GMP, GLP, GCP QC, NF USP, BP, ISO, ANSI, AAMI, AOAC, BAM, raw material, in-process, and finished product, testing.
 Contract Laboratory .com
Find FDA GMP, GLP, GCP, ISO, CLIA, UKAS, AAALAC, A2LA, & Other Laboratories for All your Laboratory Testing & Scientific Research!
Regulatory Services and Regualtory products such as Consulting, Document Management Systems, Regulatory Submission Software, Audits, Guidelines, Compliance, Training, Labeling Reviews, Import and Export, Guidance Materials, Submissions, Filings, CertificationsGlobal Regulatory
International Regulatory Consultants for all your Regulatory Needs ! Consulting | Compliance | Submissions | Audits | Training
Login / Control Panel | Contact Us | Site Map Follow Global Regulatory - Consulting, Audits, Training on Twitter!
Register Regulatory Consultants Submit Regulatory Consulting Requests
Home
Regulatory Directories
Regulatory Careers
Regulatory Events
Regulatory Resources
Regulatory News

Account Management

Welcome!
You are not logged in.

Regulatory Consulting
Regulatory Directories
Legal and Regulatory News
Regulatory Training and Conferences
 
 

Global Regulatory News Center

ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Avomeen Analytical Servics, a Full-Service Chemical Test Laboratory renewed their registration with Contract Laboratory.com's premier Laboratory Outsourcing Network. Avomeen Analytical Services is a full-service chemical testing laboratory specializing in investigative analysis, deformulation, emergency services, and expert witness testimony. Solving Your Toughest Problems Everything Avomeen does, from the design of our facilities, to the development of our management team, to the daily operation Avomeen Analytical Services, a Full-Service Chemical Testing Laboratory Renews it's Registration with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Avomeen Analytical Servics, a Full-Service Chemical Test Laboratory renewed their registration with Contract Laboratory.com's premier Laboratory Outsourcing Network. Avomeen Analytical Services is a full-service chemical testing laboratory specializing in investigative analysis, deformulation, emergency services, and expert witness testimony. Solving Your Toughest Problems Everything Avomeen does, ( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Whitehouse Laboratories renewed their registrationwith Contract Laboratory.com's premier Laboratory Outsourcing Network. Whitehouse Analytical Laboratories is a GMP-compliant, FDA regulated and inspected testing facility serving pharmaceutical, biotechnology and other FDA regulated industries. As a full-service chemistry-based laboratory, the organization's entire staff is committed to meeting your testing requirements with exactitude, quality and fast turn-around times. All work completed by the laborat Whitehouse Analytical Laboratories, a GMP Compliant and FDA Registered Laboratory Renews it's Registration with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Whitehouse Laboratories renewed their registrationwith Contract Laboratory.com's premier Laboratory Outsourcing Network. Whitehouse Analytical Laboratories is a GMP-compliant, FDA regulated and inspected testing facility serving pharmaceutical, biotechnology and other FDA regulated industries. As a full-service chemistry-based laboratory, the organization's entire staff is committed to meeting your testing( read more).....
Medical advances facilitated by NSF-funded foundational research provide alternative to large, costly and cumbersome storage infrastructure racks of servers at the University of Chicago Kenwood Data Center. The Open Science Data Cloud comprises ten racks at the University of Chicago Kenwood Data Center. Credit and Larger Version May 15, 2013 The University of Chicago launched the first secure cloud-based computing system that enables researchers to access and analyze human genomic cancer information without the costly and cumbersome infrastructure normally needed to down University of Chicago Launches Bionimbus Protected Data Cloud to Analyze Cancer Data
Medical advances facilitated by NSF-funded foundational research provide alternative to large, costly and cumbersome storage infrastructure racks of servers at the University of Chicago Kenwood Data Center. The Open Science Data Cloud comprises ten racks at the University of Chicago Kenwood Data Center. Credit and Larger Version May 15, 2013 The University of Chicago launched the first secure cloud-based computing system that enables researchers to access and analyze human( read more).....
Technology in Health (PATH), Bharat Biotech International, Ltd., and the scientists, government and people of India on the important results from the ROTAVAC rotavirus vaccine study External Web Site Policy. Highly contagious rotaviruses are the leading cause of severe diarrheal illnesses among infants and young children in both developed and resource-limited countries. Each year, rotavirus-induced diarrheal disease kills roughly 435,000 children younger than 5 years old and hospitalizes an estimated two million children worldwide, largely in developing countries. The youngest children - th Results of the ROTAVAC Rotavirus Vaccine Study in India
Technology in Health (PATH), Bharat Biotech International, Ltd., and the scientists, government and people of India on the important results from the ROTAVAC rotavirus vaccine study External Web Site Policy. Highly contagious rotaviruses are the leading cause of severe diarrheal illnesses among infants and young children in both developed and resource-limited countries. Each year, rotavirus-induced diarrheal disease kills roughly 435,000 children younger than 5 years old and hospitalizes an e( read more).....
NIH-funded trial seeks volunteers to help discover ways to delay or prevent T1D People with a family history of type 1 diabetes can now conveniently participate in free screening to help find ways to delay or prevent the disease, even if they live far from a study site. This alternative to site-based initial screening comes as modern technology enables more secure online registration for medical research. Kit with questionnaire and vial for blood test After volunteers consent online to participate in Type 1 Diabetes TrialNet - a study aimed at discovering ways to delay or prevent Type 1 diabetes network expands reach with online sign-up, nationwide testing
NIH-funded trial seeks volunteers to help discover ways to delay or prevent T1D People with a family history of type 1 diabetes can now conveniently participate in free screening to help find ways to delay or prevent the disease, even if they live far from a study site. This alternative to site-based initial screening comes as modern technology enables more secure online registration for medical research. Kit with questionnaire and vial for blood test After volunteers consent onlin( read more).....
WASHINGTON, DC - May 14, 2013 - Microscopic algae that live within reef-forming corals scoop up available nitrogen, store the excess in crystal form, and slowly feed it to the coral as needed, according to a study published in mBio®, the online open-access journal of the American Society for Microbiology. Scientists have known for years that these symbiotic microorganisms serve up nitrogen to their coral hosts, but this new study sheds light on the dynamics of the process and reveals that the algae have the ability to store excess nitrogen, a capability that could help corals cope in their chr Microbes capture, store, and release nitrogen to feed reef-building coral
WASHINGTON, DC - May 14, 2013 - Microscopic algae that live within reef-forming corals scoop up available nitrogen, store the excess in crystal form, and slowly feed it to the coral as needed, according to a study published in mBio®, the online open-access journal of the American Society for Microbiology. Scientists have known for years that these symbiotic microorganisms serve up nitrogen to their coral hosts, but this new study sheds light on the dynamics of the process and reveals that the al( read more).....
New use for Tarceva also approved The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC). The test is being approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the body (metastasized) and who have certain mutations in FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer
New use for Tarceva also approved The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC). The test is being approved with an expanded use for Tarceva as a first-line treatment for patients wit( read more).....
Contract Laboratory.com - The Laboratory Outsource Network! is pleased to announce that FAI MATERIALS TESTING LABORATORIES, Marietta, GA has registered with Contract Laboratory.com. FAI Materials Testing Laboratory is a full service analytical, failure analysis, and materials testing laboratory providing clients great service at a reasonable price. We are professional scientists, chemists, and engineers with decades of experience solving problems in a host of industries. FAI Materials Testing Laboratories offer a variety of Laboratory, Consulting, and Expert Witness Services to assist FAI MATERIAL TESTING LABORATORY Registers with Contract Laboratory .com
Contract Laboratory.com - The Laboratory Outsource Network! is pleased to announce that FAI MATERIALS TESTING LABORATORIES, Marietta, GA has registered with Contract Laboratory.com. FAI Materials Testing Laboratory is a full service analytical, failure analysis, and materials testing laboratory providing clients great service at a reasonable price. We are professional scientists, chemists, and engineers with decades of experience solving problems in a host of industries. FAI Materials Te( read more).....
WASHINGTON, DC - May 7, 2013 -- To infect its host, the respiratory pathogen Pseudomonas aeruginosa takes an ordinary protein usually involved in making other proteins and adds three small molecules to turn it into a key for gaining access to human cells. In a study to be published May 7 in mBio®, the online open-access journal of the American Society for Microbiology, scientists at Emory University School of Medicine, the University of Virginia, and Universidad de las Islas Baleares in Mallorca, Spain, uncover this previously unknown virulence factor in P. aeruginosa, one of the most common c Pathogen turns protein into a virulence factor in one easy step
WASHINGTON, DC - May 7, 2013 -- To infect its host, the respiratory pathogen Pseudomonas aeruginosa takes an ordinary protein usually involved in making other proteins and adds three small molecules to turn it into a key for gaining access to human cells. In a study to be published May 7 in mBio®, the online open-access journal of the American Society for Microbiology, scientists at Emory University School of Medicine, the University of Virginia, and Universidad de las Islas Baleares in Mallorca( read more).....
CDC reinforces need for appropriate follow-up testing for current infection Only half of Americans identified as ever having had hepatitis C received follow-up testing showing that they were still infected, according to a Centers for Disease Control and Prevention analysis of data from a multi-area study published today in the CDC report Vital Signs. Study suggests only half of Americans with hepatitis C receive complete testing for the virus
CDC reinforces need for appropriate follow-up testing for current infection Only half of Americans identified as ever having had hepatitis C received follow-up testing showing that they were still infected, according to a Centers for Disease Control and Prevention analysis of data from a multi-area study published today in the CDC report Vital Signs. "Many people who test positive on an initial hepatitis C test are not receiving the necessary follow-up test to know if their body has clear( read more).....
WASHINGTON, DC - April 30, 2013 - Scientists have devised a method for delivering tumor cell-killing enzymes in a way that protects the enzyme until it can do its work inside the cell. In their study in mBio®, the online open-access journal of the American Society for Microbiology, researchers assembled microscopic protein packages that can deliver an enzyme called PEIII to the insides of cells. By attaching a protein called ubiquitin to the enzyme, they were able to protect it from degradation by the cell, allowing the enzyme to complete its mission. The results indicate that ubiquitin may be Protein Improves Efficacy of Tumor-killing Enzyme
WASHINGTON, DC - April 30, 2013 - Scientists have devised a method for delivering tumor cell-killing enzymes in a way that protects the enzyme until it can do its work inside the cell. In their study in mBio®, the online open-access journal of the American Society for Microbiology, researchers assembled microscopic protein packages that can deliver an enzyme called PEIII to the insides of cells. By attaching a protein called ubiquitin to the enzyme, they were able to protect it from degradation ( read more).....
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients. Sterile drug products that are contaminated place patients at risk of serious infection. The FDA advises health care providers and hospital staff to immediately check their medical supplies and quarantin FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients. Sterile drug products that are contaminated place patients at risk of serious infection. The FDA advise( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Michor-Consulting-e.u. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. At Michor Consulting our mission is to provide the highest quality services for our clients at the right time. The life science industry has, until recently, been characterised by rapid growth through the development of pharmaceutical blockbusters and/or innovation in medical technology. More recently growth via Mergers and acquisitions (M&As) has become commo Michor-Consulting-e.u. Renews with GlobalRegulatory.com!
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Michor-Consulting-e.u. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. At Michor Consulting our mission is to provide the highest quality services for our clients at the right time. The life science industry has, until recently, been characterised by rapid growth through the development of pharmaceutical blockbusters and/or innovat( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Y.M.G. Services has registered with GlobalRegulatory.com the premier International Regulatory Consulting Outsourcing Network. YMG services is a professional, experienced, consulting group focused on the medical device industry. Our services include advice on international global Regulatory affairs, Clinical research and global Quality Assurance (QA) for the medical device and cosmetics industries. Our experienced team consists of experts in Pre Market regulatory submissions, facility inspections, clinica Y.M.G. Services Registers with GlobalRegulatory.com!
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Y.M.G. Services has registered with GlobalRegulatory.com the premier International Regulatory Consulting Outsourcing Network. YMG services is a professional, experienced, consulting group focused on the medical device industry. Our services include advice on international global Regulatory affairs, Clinical research and global Quality Assurance (QA) for the medical device and cosmetics industries. Our expe( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that MDI Consultants, Inc. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. MDI Consultants, Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. Since 1978 we have been providing clients the following high-quality and high-value consulting services: FDA compliance - regulatory strategy development, clinical trial development/ manageme MDI Consultants, Inc. Renews with GlobalRegulatory.com!
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that MDI Consultants, Inc. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. MDI Consultants, Inc. is the leading provider of quality assurance, regulatory compliance and clinical services to the Medical Device, Pharmaceutical and Food industries. Since 1978 we have been providing clients the following high-quality and high-value consulti( read more).....
Contract Laboratory.com - The Laboratory Outsource Network! is pleased to announce that IBR-Inc. registered with Contract Laboratory.com. IBR Inc. is a Swiss contract research organisation with a core competence in inflammation research and over 10 years experience of providing preclinical and clinical R&D services to biotechnology and pharmaceutical companies. A multidisciplinary team of scientists, GLP-compliant laboratories and a broad portfolio of validated methods cover the drug development process from early lead optimization to clinical studies. Ensuring access to expert knowledge in IBR-Inc. Registers with Contract Laboratory .com
Contract Laboratory.com - The Laboratory Outsource Network! is pleased to announce that IBR-Inc. registered with Contract Laboratory.com. IBR Inc. is a Swiss contract research organisation with a core competence in inflammation research and over 10 years experience of providing preclinical and clinical R&D services to biotechnology and pharmaceutical companies. A multidisciplinary team of scientists, GLP-compliant laboratories and a broad portfolio of validated methods cover the drug developm( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Rosam Legal & Consulting Group, LLc has Registered with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Rosam Legal & Consulting Group, LLC is located at 6123 Rose Bay Drive, Forestville, MD 20747 and founded by Retford Berko, Esq. Rosam Legal & Consulting Group, LLC has over 30 years of experience in the regulatory Drugs, Medical Device & Biologics fields. Retford Berko is an experienced FDA Attorney with expertise in medical devices, drugs, biologics and Rosam Legal & Consulting Group, LLC Registers with GlobalRegulatory.com
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Rosam Legal & Consulting Group, LLc has Registered with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Rosam Legal & Consulting Group, LLC is located at 6123 Rose Bay Drive, Forestville, MD 20747 and founded by Retford Berko, Esq. Rosam Legal & Consulting Group, LLC has over 30 years of experience in the regulatory Drugs, Medical Device & Biologics fields. ( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Advanced Medicals Consortium has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Advanced Medicals Consortium's vertical integration allows our clients the benefit of industry expertise in the Medical Device, Pharmaceuticals and Biotechnology domains. Our qualified national associates have experience and expertise communicating directly with the FDA regarding regulatory guidance, medical device submissions and post-marketing surveilla Advanced Medicals Consortium Renews with GlobalRegulatory.com
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Advanced Medicals Consortium has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Advanced Medicals Consortium's vertical integration allows our clients the benefit of industry expertise in the Medical Device, Pharmaceuticals and Biotechnology domains. Our qualified national associates have experience and expertise communicating directly( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxicology Research Laboratory renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. The Toxicology Research Laboratory has significant 20-year experience in preclinical safety and efficacy assessment programs. These include acute, subchronic, and chronic toxicity studies; reproductive and developmental toxicity studies; neurobehavioral toxicity studies; and pharmacokinetics, metabolism, and disposition studies. Expertise in neuropharmacology, cardiovascular and safety pharmaco Toxicology Research Laboratory Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxicology Research Laboratory renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. The Toxicology Research Laboratory has significant 20-year experience in preclinical safety and efficacy assessment programs. These include acute, subchronic, and chronic toxicity studies; reproductive and developmental toxicity studies; neurobehavioral toxicity studies; and pharmacokinetics, meta( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Micromyx renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Micromyx is a microbiology services company specializing in anti-infective discovery and development for the pharmaceutical, biotechnology, and animal health industries. Founded in 2004 by former pharmaceutical industry infectious disease scientists, Micromyx is a unique contract research organization that offers clients documented, top of the line laboratory services from experts who have successfully gained FDA appr Micromyx Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Micromyx renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Micromyx is a microbiology services company specializing in anti-infective discovery and development for the pharmaceutical, biotechnology, and animal health industries. Founded in 2004 by former pharmaceutical industry infectious disease scientists, Micromyx is a unique contract research organization that offers client( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Nova Biologicals renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Since 1993, Nova has specialized in every aspect of microbiology testing. For the medical device, pharmaceutical, personal care, and food and beverage industries Nova provides FDA/USP related microbiology testing services. Nova also performs U.S. EPA related microbiology testing for public drinking water systems and indoor air quality. For the medical device, pharmaceutical, personal care, and food/bever Nova Biologicals Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Nova Biologicals renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Since 1993, Nova has specialized in every aspect of microbiology testing. For the medical device, pharmaceutical, personal care, and food and beverage industries Nova provides FDA/USP related microbiology testing services. Nova also performs U.S. EPA related microbiology testing for public drinking water syste( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that KWS BioTest renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. KWS BioTest is an established contract research organisation that brings together internationally renowned scientific expertise in a commercially managed environment for the testing of prophylactic and therapeutic agents as treatments for human disease. Formed in 2004, KWS BioTest originates from the University of Bristol, and operates in state of the art facilities focused on contract research. The ability to br KWS BioTest Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that KWS BioTest renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. KWS BioTest is an established contract research organisation that brings together internationally renowned scientific expertise in a commercially managed environment for the testing of prophylactic and therapeutic agents as treatments for human disease. Formed in 2004, KWS BioTest originates from the University of ( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that IPS Therapeutique renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. IPS Therapeutique is a specialty Contract Research Organization which dedicates its expertise and technology to the evaluation of the cardiac safety of new drugs at an early stage of their development, by using validated and highly predictive models. Recognized for the quality and the on-time delivery of its IND enabling studies, IPS Therapeutique addresses the particular needs of start-up and mature biopha IPS Therapeutique Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that IPS Therapeutique renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. IPS Therapeutique is a specialty Contract Research Organization which dedicates its expertise and technology to the evaluation of the cardiac safety of new drugs at an early stage of their development, by using validated and highly predictive models. Recognized for the quality and the on-time delivery of its ( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Exponent renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. With over 90 scientific and engineering disciplines, Exponent's staff of approximately 900, located in 19 offices throughout the nation and 5 international offices, combines unparalleled technical expertise with the ability, when necessary, to focus this knowledge in extremely short time frames. Our multidisciplinary team of scientists, physicians, engineers, and regulatory consultants will perform either in-depth sci Exponent Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Exponent renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. With over 90 scientific and engineering disciplines, Exponent's staff of approximately 900, located in 19 offices throughout the nation and 5 international offices, combines unparalleled technical expertise with the ability, when necessary, to focus this knowledge in extremely short time frames. Our multidisciplinary te( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxikon USA renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Toxikon's mission and commitment continues to focus on providing quality services, competitively priced, with on-time delivery. In today's competitive market, the need for our clients to enter into a business partnership, not simply a contractual relationship, is critical to our operating philosophy and success. Toxikon designs solutions that satisfy the clients' needs, and we measure our success by a proven ability Toxikon USA Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxikon USA renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. Toxikon's mission and commitment continues to focus on providing quality services, competitively priced, with on-time delivery. In today's competitive market, the need for our clients to enter into a business partnership, not simply a contractual relationship, is critical to our operating philosophy and success. Toxik( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxicology Research Laboratory renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. The Toxicology Research Laboratory has significant 20-year experience in preclinical safety and efficacy assessment programs. These include acute, subchronic, and chronic toxicity studies; reproductive and developmental toxicity studies; neurobehavioral toxicity studies; and pharmacokinetics, metabolism, and disposition studies. Expertise in neuropharmacology, cardiovascular and safety pharmacol Toxicology Research Laboratory Renews with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Toxicology Research Laboratory renewed with Contract Laboratory.com's premier Laboratory Outsourcing Network. The Toxicology Research Laboratory has significant 20-year experience in preclinical safety and efficacy assessment programs. These include acute, subchronic, and chronic toxicity studies; reproductive and developmental toxicity studies; neurobehavioral toxicity studies; and pharmacokinetics, metab( read more).....
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Beckloff Associates, Inc. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Beckloff Associates, a Cardinal Health company, provides a wide range of consulting services required to obtain marketing approval for drugs, biologics and medical devices for the U.S., Canadian and European markets. Our goal is to help biotechnology, pharmaceutical and medical device customers increase the financial return on their research investments thro Beckloff Associates, Inc. Renews Registration with GlobalRegulatory.com
GlobalRegulatory.com - The International Regulatory Network! is proud to announce that Beckloff Associates, Inc. has renewed their registration with GlobalRegulatory.com's premier International Regulatory Consulting Outsourcing Network. Beckloff Associates, a Cardinal Health company, provides a wide range of consulting services required to obtain marketing approval for drugs, biologics and medical devices for the U.S., Canadian and European markets. Our goal is to help biotechnology, pharmace( read more).....
Agency participates in international Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites. The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a globa US Food and Drug Administration FDA takes action against thousands of illegal Internet pharmacies
Agency participates in international Operation Pangea V to protect consumers from potentially dangerous, unapproved drugs The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites. The ( read more).....
The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart. An implantable defibrillator is a small battery-powered device that constantly monitors a person's heart rhythm and can deliver a therapeutic dose of electricity to restore the rhythm when it senses the heart is beating dangerously fast (tachycardia) or chaotically (sudden cardiac arrest). Other implantable defibrillators on the market require a physician US Food and Drug Administration FDA approves first subcutaneous heart defibrillator
The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart. An implantable defibrillator is a small battery-powered device that constantly monitors a person's heart rhythm and can deliver a therapeutic dose of electricity to restore the rhythm when it senses the heart is beating dangerously fast (tachycardia) or chaotica( read more).....
GlobalRegulatory.com - The International Regulatory Network! is pleased to announce that Leigh Business Group, LLC registers with Global Regulatory.com Leigh Business Group, LLC - Regulatory Compliance Consulting Firm Cosmetics & OTCs: Leigh Business Group LLC was founded by Lisa A. Leigh in 2011. Lisa A. Leigh is an experienced licensed Attorney and Regulatory Affairs Professional with a multifaceted knowledge of domestic and international regulations concerning beauty, cosmetic and personal care products. She has over 15 years of combined legal and regulatory experience working in Leigh Business Group, LLC Registers with GlobalRegulatory.com
GlobalRegulatory.com - The International Regulatory Network! is pleased to announce that Leigh Business Group, LLC registers with Global Regulatory.com Leigh Business Group, LLC - Regulatory Compliance Consulting Firm Cosmetics & OTCs: Leigh Business Group LLC was founded by Lisa A. Leigh in 2011. Lisa A. Leigh is an experienced licensed Attorney and Regulatory Affairs Professional with a multifaceted knowledge of domestic and international regulations concerning beauty, cosmetic and perso( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Exova UK Laboratory registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. Exova is the world's largest dedicated testing group, trusted by leading organisations to test and advise on the safety, quality and performance of their products and operations. With experience built over 40 years, our customers look to our experts to deliver technically demanding services that help to extend asset life, bring predictability to applications and shorten the time to market for products Exova UK Laboratory Registers with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Exova UK Laboratory registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. Exova is the world's largest dedicated testing group, trusted by leading organisations to test and advise on the safety, quality and performance of their products and operations. With experience built over 40 years, our customers look to our experts to deliver technically demanding services that help to( read more).....
The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults. Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins that play an important role in abnormal inflammatory and immune responses. Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. It is on US Food and Drug Administration FDA approves Humira to treat ulcerative colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults. Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins that play an important role in abnormal inflammatory and immune responses. Ulcerative colitis is a chro( read more).....
Priority review completed one month ahead of goal date The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic). Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. Stivarga is being approv US Food and Drug Administraiton FDA approves new treatment for advanced colorectal cancer
Priority review completed one month ahead of goal date The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic). Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Brainport Development registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. Brainport Eindhoven Region, according to the Intelligent Community Forum (ICF) the world's smartest region in 2011, is a top technology breeding ground for innovation and home to world-class businesses, knowledge institutes and research institutions. Together they design and manufacture the technology of the future to ensure a safe, green and caring society and sustainable economic development of the Ne Brainport Development Registers with ContractLaboratory.com
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Brainport Development registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. Brainport Eindhoven Region, according to the Intelligent Community Forum (ICF) the world's smartest region in 2011, is a top technology breeding ground for innovation and home to world-class businesses, knowledge institutes and research institutions. Together they design and manufacture the technology of ( read more).....
The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). U.S. Food and Drug Administration FDA approves new multiple sclerosis treatment Aubagio
The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). "In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thin( read more).....
Mayo Clinic is the first facility approved to manufacture Choline C 11 Injection The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer. PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) leve U.S. Food and Drug Administration FDA approves production of imaging agent that helps detect prostate cancer
Mayo Clinic is the first facility approved to manufacture Choline C 11 Injection The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer. PET imaging w( read more).....
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Chilworth registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. As the world's leading one-stop source for industry's process safety and optimization needs, the Chilworth Global has international consulting bases and laboratory testing facilities with state of the art dust explosion and electrostatic laboratories (with low humidity facility), and a specialist laboratory for the evaluation of thermal runaway reactions. Chilworth employs a Doctorate Engineering and Scientific Chilworth Registers with Contract Laboratory .com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Chilworth registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. As the world's leading one-stop source for industry's process safety and optimization needs, the Chilworth Global has international consulting bases and laboratory testing facilities with state of the art dust explosion and electrostatic laboratories (with low humidity facility), and a specialist laboratory for the e( read more).....
The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders. The products cited in the warning letters include Trinity Sports Group's Neuro Impact Concussion Response Formula and PruTect Rx's NeuroPruTect and Omega3PruTect. These products are in capsule and powder forms. They are marketed online in the United States and internationa U.S. Food and Drug Administration FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs
The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders. The products cited in the warning letters include Trinity Sports Group's Neuro Impact Concussion Response Formula and PruTect Rx's NeuroPruTect and Omega3PruTect. These prod( read more).....
The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells called granulocytes. Granulocytes fight infection. Bosulif is intended for patients with chronic, The U.S. Food and Drug Administration FDA approves new orphan drug for chronic myelogenous leukemia
The U.S. Food and Drug Administration today approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults. An estimated 5,430 men and women will be diagnosed with CML in 2012. Most people with CML have a genetic mutation, called the Philadelphia chromosome, which causes the bone marrow to make an enzyme called tyrosine kinase. This enzyme triggers the development of too many abnormal and unhealthy white blood cells ( read more).....
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA's priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received The U.S. Food and Drug Administration FDA approves new treatment for a type of late stage prostate cancer
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA's priority review program. The program provides for an expedited six-month review for drugs that may offer major( read more).....
The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. Additionally, an estimated 15.3 million people are affected by IBS. IBS-C is a subtype characterized mainly by abdominal pain and by hard or lump The U.S. Food and Drug Administration FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation
The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. Additionally, an estimated 15.3 million peopl( read more).....
The U.S. Food and Drug Administration today approved Sicor Biotech's tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow. This reduction in neutrophils may lead to infection and fever (febrile neutropenia). Tbo-fil The U.S. Food and Drug Administration FDA approves new treatment for severe neutropenia in certain cancer patients
The U.S. Food and Drug Administration today approved Sicor Biotech's tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils. Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone mar( read more).....
The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended to treat patients ages 1 year and older with tuberous sclerosis complex (TSC) who are diagnosed with SEGA that cannot be treated with surgery. Prior to approval of this new do The U.S. Food and Drug Administration FDA approves first drug formulated for children with rare brain tumor
The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor. Afinitor Disperz is recommended to treat patients ages 1 year and older with tuberous sclerosis complex (TS( read more).....
La Administraci�n de Alimentos y Medicamentos de los EE.UU. aprob� hoy Stribild (elvitegravir, cobicistat, emtricitabina, fumarato disoproxilo de tenofovir), una nueva p�ldora de combinaci�n que se toma una vez al d�a para el tratamiento de la infecci�n del VIH-1 en adultos que nunca han recibido tratamiento contra la infecci�n del VIH. Stribild contiene dos medicamentos contra el VIH previamente aprobados, m�s dos nuevos medicamentos: elvitegravir y cobicistat. El medicamento elvitegravir es un inhibidor de integrasa o de transferencia de cadena, un medicamento que interfie La FDA aprueba una nueva p�ldora de combinaci�n para el tratamiento del VIH en algunos pacientes In English1
La Administraci�n de Alimentos y Medicamentos de los EE.UU. aprob� hoy Stribild (elvitegravir, cobicistat, emtricitabina, fumarato disoproxilo de tenofovir), una nueva p�ldora de combinaci�n que se toma una vez al d�a para el tratamiento de la infecci�n del VIH-1 en adultos que nunca han recibido tratamiento contra la infecci�n del VIH. Stribild contiene dos medicamentos contra el VIH previamente aprobados, m�s dos nuevos medicamentos: elvitegravir y cobicistat. El medicamento( read more).....
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to The U.S. Food and Drug Administration FDA approves new combination pill for HIV treatment for some patients
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection. Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicista( read more).....
U.S. Marshals have seized food products stored in a Fremont, Calif., company's warehouse after inspectors from the U.S. Food and Drug Administration found widespread and active rodent infestation. The FDA initiated the seizure of various food products in the warehouse owned by the San Francisco Herb &Natural Food Company on Aug. 21, 2012, under a warrant issued by the U.S. District Court for the Northern of California. FDA inspectors found significant insanitary conditions throughout the warehouse during a recent inspection, in violation of the Federal Food, Drug, and Cosmetic Act. The The U.S. Food and Drug Administration FDA: U.S. Marshals seize food products at Fremont, Calif., warehouse Agency acts to prevent food distribution from rodent-infested facility
U.S. Marshals have seized food products stored in a Fremont, Calif., company's warehouse after inspectors from the U.S. Food and Drug Administration found widespread and active rodent infestation. The FDA initiated the seizure of various food products in the warehouse owned by the San Francisco Herb &Natural Food Company on Aug. 21, 2012, under a warrant issued by the U.S. District Court for the Northern of California. FDA inspectors found significant insanitary conditions throughout the( read more).....
The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels. The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning U.S. Food and Drug Administration FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium
The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels. The FDA has received dozens of additional adverse event reports, including ( read more).....
The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes. Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 15 milligram, 30 mg and 45 mg pioglitazone tablets. The U.S. Food and Drug Administration FDA approves first generic Actos to treat type 2 diabetes
The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes. Mylan Pharmaceuticals, based in Morgantown, W.Va., gained FDA approval for 15 milligram, 30 mg and 45 mg pioglitazone tablets. "Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes," ( read more).....
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata1 and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart. The manufacturer of the leads, St. Jude Medical, recalled2 them in November 2011 after reports of premature erosion of the insulation around the electrical conductor wires, also called insulation failure. St. Jude Medical, located The U.S. Food and Drug Administration FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment Agency orders the company to collect data on the wire insulation function
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata1 and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart. The manufacturer of the leads, St. Jude Medical, recalled2 them in November 2011 after reports of premature erosion of the insulati( read more).....
The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy). The surgeries were performed to treat obstructive sleep apnea syndrome, a condition that results in repeated episodes of complete or partial blockage of the upper airway during sleep. The children received doses of codeine that were within the typical dose range. The U.S. Food and Drug Administration FDA warns of risk of death from codeine use in some children following surgeries
The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy). The surgeries were performed to treat obstructive sleep apnea syndrome, a condition that results in repeated episodes of complete or partial blockage of the upper ai( read more).....

 
Are you a Regulatory Consultant that is serious about finding new clients and developing more business? Get a Regulatory Consultant's Profile in our high traffic Regulatory Consultant's Directories.
Find attorneys, quality consultants and regulatory consultants in the pharmaceutical, healthcare, medical devices, in-vitro diagnostic, chemical, biopharmaceutical, clinical trials, personal care, veterinary medicine, life sciences, food and beverage, in-vitro diagnostics, biotechnology, dietary supplements, veterinary drugs, and cosmetics industries for USA, Canada, European Union, Asia, Japan regulatory consulting, submissions, training, compliance, expert witnesses, scientific reviews, certifications, guidance, validation, technical writing, export, import, labeling reviews, and audits such as US FDA, GMP, GLP, GCP, ISO, EMEA, Health Canada, TGA, IVDD, MDD compliance, PMA, NDA ANDA submissions, ICH GCP, GMP audits,etc.
Global Regulatory .com can assist your company in finding Regulatory Consultants for legal and regulatory services such as submissions, certifications, licensing, quality systems, technical writing, importing / exporting, expert witnesses, audits, consulting, scientific reviews, designated agents, compliance, validation, qualification, training, etc in industries such as:
Avomeen Analytical Services, a Full-Service Chemical Testing Laboratory Renews it's Registration with ContractLaboratory.com
2013-05-21 00:00:00
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Avomeen Analytical Servics, a Full-Service Chemical Test Labora... 

Whitehouse Analytical Laboratories, a GMP Compliant and FDA Registered Laboratory Renews it's Registration with ContractLaboratory.com
2013-05-20 00:00:00
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Whitehouse Laboratories renewed their registrationwith Contract... 

University of Chicago Launches Bionimbus Protected Data Cloud to Analyze Cancer Data
2013-05-15 00:00:00
Medical advances facilitated by NSF-funded foundational research provide alternative to large, costly and cumbersome storage infrastructure rack... 

Results of the ROTAVAC Rotavirus Vaccine Study in India
2013-05-15 00:00:00
Technology in Health (PATH), Bharat Biotech International, Ltd., and the scientists, government and people of India on the important results from the ... 

Type 1 diabetes network expands reach with online sign-up, nationwide testing
2013-05-15 00:00:00
NIH-funded trial seeks volunteers to help discover ways to delay or prevent T1D People with a family history of type 1 diabetes can now convenie... 

Microbes capture, store, and release nitrogen to feed reef-building coral
2013-05-14 00:00:00
WASHINGTON, DC - May 14, 2013 - Microscopic algae that live within reef-forming corals scoop up available nitrogen, store the excess in crystal form, ... 

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer
2013-05-14 00:00:00
New use for Tarceva also approved The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for ... 

FAI MATERIAL TESTING LABORATORY Registers with Contract Laboratory .com
2013-05-14 00:00:00
Contract Laboratory.com - The Laboratory Outsource Network! is pleased to announce that FAI MATERIALS TESTING LABORATORIES, Marietta, GA has registere... 

Pathogen turns protein into a virulence factor in one easy step
2013-05-07 00:00:00
WASHINGTON, DC - May 7, 2013 -- To infect its host, the respiratory pathogen Pseudomonas aeruginosa takes an ordinary protein usually involved in maki... 

Study suggests only half of Americans with hepatitis C receive complete testing for the virus
2013-05-07 00:00:00
CDC reinforces need for appropriate follow-up testing for current infection Only half of Americans identified as ever having had hepatitis C receiv... 

Protein Improves Efficacy of Tumor-killing Enzyme
2013-04-30 00:00:00
WASHINGTON, DC - April 30, 2013 - Scientists have devised a method for delivering tumor cell-killing enzymes in a way that protects the enzyme until i... 

FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall
2013-04-15 00:00:00
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ... 

Submit Legal and Regulatory News and Press Releases

View More Legal and Regulatory News

Global Regulatory .com values your privacy. For more information on our Privacy Policy, please visit Privacy Policy This site is owned and managed by Global Regulatory, Inc.

Please also visit Contract Laboratory.com,, Contract Clinical.com