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The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to participate in the pilot programme and all 33 applicants will have the opportunity to be assessed over the next 10 months. The assessments will be carried out in two stages, with a pilot group of 20 applicants commencing their assessments immediately and the remaining 13 applicants commencing their assessments in a second stage programme from Ap UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to participate in the pilot programme and all 33 applicants will have the opportunity to be assessed over the next 10 months. The assessments will be carried out in two stages, with a pilot group of 20 applicants commencing their assessments immediat( read more).....
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary catheter to an overnight drainage bag. It gives users the opportunity to retrain the bladder and reduce the reliance on urine bags. The recall is being conducted because a routine sterility test on the Trident Catheter Valve in a particular set of lots has failed. This raised concerns that the valves in these lots may not be sterile. To date, no Trident catheter valve - Model Number: 380851
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary catheter to an overnight drainage bag. It gives users the opportunity to retrain the bladder and reduce the reliance on urine bags. The recall is being conducted because a routine sterility test on the Trident Catheter Valve in a particular set of lot( read more).....
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undertaken over the past 18 months. These reviews include: the review to improve the transparency of the public consultations on the regulatory framework for advertising therapeutic goods the Auditor-General's report on Therapeutic Goods Regulation: Complementary Medicines an informal working group examining the regulation of complementa TGA reforms: a blueprint for TGA's future
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undertaken over the past 18 months. These reviews include: the review to improve the transparency of the public consultations on the regulatory framework for advertising therapeutic goods the Auditor-General's report on Therapeutic Goods Regu( read more).....
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our organization:  ISO 17025 Certification for Continued Excellence in Test Execution and Quality Cont Respirtek ISO 17025 Business Management Improvements
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our orga( read more).....
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our organization:  ISO 17025 Certification for Continued Excellence in Test Execution and Quality Cont Respirtek, Inc. ISO 17025 Accreditation Announcement
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our orga( read more).....
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, where Jacobs' readiness to proceed to the initial assessment stage was established and an action plan was agreed. At the initial assessment, UKAS will establish the inspection body's compliance with the international standard ISO/IEC 17020, Generic criteria for the operation of various types of bodies performing inspection, and its competence to per UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, where Jacobs' readiness to proceed to the initial assessment stage was established and an action plan was agreed. At the initial assessment, UKAS will establish the inspection body's compliance with the international standard ISO/IEC 17020, Generic cr( read more).....
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving the energy efficiency of British properties, new accreditation activity in support of plant health inspections, crime scene investigations and telecommunications services, as well as general background on UKAS and accreditation. Accreditation Matters continues to be an effective means of increasing the level of knowledge of accreditation acro ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving the energy efficiency of British properties, new accreditation activity in support of plant health inspections, crime scene investigations and telecommunications services, as well as general background on UKAS and accreditation. Accreditation M( read more).....
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of USP <71> is important to the radiopharmaceutical industry because it allows us to assist in designing a sterility test validation process. USP <71> testing of radiopharmaceuticals is a scientifically complex process that must be performed by trained and qualified radiological and microbiological laboratory personnel. Nova's highly qualified and exp Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of USP <71> is important to the radiopharmaceutical industry because it allows us to assist in designing a sterility test validation process. USP <71> testing of radiopharmaceuticals is a scientifically complex process that must be performed by trained ( read more).....
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA. In August 2011, the agency released the strategic plan for: FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA. In August 2011, the agency released the strategic plan for( read more).....
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder. Schizophrenia is a chronic, severe, and disabling brain disorder. About 1 percent of Americans have this illness. Symptoms people with schizophrenia have include: hearing voices, believing other people are reading their minds or controlling thoughts, and being suspicious or withdrawn. Bipolar
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder. Schizophrenia is a chronic, severe, and disabling brain disorder. About 1 percent of Americans have this illness. Symptoms people with schizophrenia have include: hearing voices, believing other pe( read more).....
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA. FDA approves Onfi to treat severe type of seizures
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA. "Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," said Russell K( read more).....
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warrant issued by the U.S. District Court for the Northern District of Illinois. The FDA initiated the seizure after finding extensive evidence of unsanitary conditions throughout the warehouse during a recent inspection. Investigators collected more than 300 samples of materials showing significant unsanitary conditions, in violation of the Federal Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warrant issued by the U.S. District Court for the Northern District of Illinois. The FDA initiated the seizure after finding extensive evidence of unsanitary conditions throughout the warehouse during a recent inspection. Investigators collected more ( read more).....
The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk). External pacemaker pulse generators are used temporarily to regulate a patient's heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats. FDA proposes lower risk classification, special controls for external pacemakers Classification of "preamendment" device clarifies FDA review process
The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk). External pacemaker pulse generators are used temporarily to regulate a patient's heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats. "The FDA has assessed ( read more).....
The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm. The standard of care to t FDA approves Ferriprox to treat patients with excess iron in the body
The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver di( read more).....
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011. The seized products had been subject to a detention order issued by FDA on Sept. 2, 2011, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility's warehouse and processing area. In a complaint filed Sept. 29, 2011, the United States alleged that the detained food was adulterated under the Federa FDA: U.S. Marshals seize foods stored at Washington State facility FDA inspection found rodent and insect infestation
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011. The seized products had been subject to a detention order issued by FDA on Sept. 2, 2011, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility's warehouse and processing area. In a complaint fil( read more).....
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a FDA, CMS launch pilot program for voluntary parallel review of innovative devices Aim is to reduce time between FDA approval and CMS national coverage determinations
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a "parallel review" pilot program for concurrent review of medical devices for FDA approval and Medicare coverage. The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The FDA and CMS anticipate that parallel review will facilitate the development of innova( read more).....
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED. Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night. The severity of symptoms of BPH can be measured using the International Pro FDA approves Cialis to treat benign prostatic hyperplasia
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED. Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urinatio( read more).....
The U.S. Food and Drug Administration and the National Institutes of Health today announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations. The initiative, called the Tobacco Control Act National Longitudinal Study of Tobacco Users, is the first large-scale NIH/FDA collaboration on tobacco regulatory research since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009. Scientific experts at NIH's National Institute FDA and NIH announce joint study on tobacco use and risk perceptions Landmark collaboration is the first since the passing of the 2009 Tobacco Control Act
The U.S. Food and Drug Administration and the National Institutes of Health today announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of new government tobacco regulations. The initiative, called the Tobacco Control Act National Longitudinal Study of Tobacco Users, is the first large-scale NIH/FDA collaboration on tobacco regulatory research since Congress granted FDA the authority to regulate tobacco products in the Family S( read more).....
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. Titled FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans. Titled "Driving Biomedical Innovation: Initiatives for Improving Products for Patients,"the blueprint addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development. "The Obama Administration is commi( read more).....
FDA's Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also conduct a 12-week pilot of the network through Dec. 30, 2011. CDRH has a world-class scientific staff that includes scientists, engineers, and clinicians. Nevertheless, there are times when staff must turn to external sources to further enhance their scientific understanding, FDA outlines plans for an outside network of scientific experts Network will help quickly address regulatory concerns, broaden staff knowledge of new and emerging technologies
FDA's Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also conduct a 12-week pilot of the network through Dec. 30, 2011. CDRH has a world-class scientific staff that includes scientists, engineers, and clinicians. Nevertheless, there ar( read more).....
The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children. A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA's Office of Orphan Products Development. The recipients and grant amounts include:  James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 FDA awards three grants to stimulate development of pediatric medical devices Grantees will work with industry and the FDA to address unmet pediatric device needs
The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children. A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA's Office of Orphan Products Development. The recipients and grant amounts include:  James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Dev( read more).....
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products. The report, FDA works to improve science used to approve medical devices
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products. The report, "Regulatory Science in FDA's Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health," offers a look at the work FDA engages in every day to help foster sci( read more).....
READING, PENNSYLVANIA, USA, October 3, 2011 - Poplar Solutions, LLC, a leader in web-based document and records management solutions for life science companies and analytical laboratories announced that the U.S. EPA Region 6 Environmental Services Branch (ESB) Laboratory, located in Houston, Texas has chosen to implement its Labcore Scientific Data Management System (SDMS) to automate its laboratory operations including data package assembly and management. The Environmental Services Branch (ESB) Laboratory serves a critical role in scientific support for Regional Quality Assurance efforts. EPA Purchases Labcore to Improve Laboratory Efficiency, Reduce Paper and Quickly Assemble Data Packages
READING, PENNSYLVANIA, USA, October 3, 2011 - Poplar Solutions, LLC, a leader in web-based document and records management solutions for life science companies and analytical laboratories announced that the U.S. EPA Region 6 Environmental Services Branch (ESB) Laboratory, located in Houston, Texas has chosen to implement its Labcore Scientific Data Management System (SDMS) to automate its laboratory operations including data package assembly and management. The Environmental Services Branch (( read more).....
Water quality and environmental health in Botswana; wetlands in a working landscape; the collapse of the ancient Maya and what that has to tell us about society and environmental change today. These and other projects that address how humans and the environment interact are the focus of $21 million in National Science Foundation (NSF) grants to scientists, engineers and educators across the country to study coupled natural and human systems. Research conducted through NSF's Dynamics of Coupled Natural and Human Systems (CNH) program, in its fifth year as a multi-directorate program, will New Understanding of How Humans and the Environment Interact National Science Foundation Grants Awarded for Research on Coupled Natural and Human Systems
Water quality and environmental health in Botswana; wetlands in a working landscape; the collapse of the ancient Maya and what that has to tell us about society and environmental change today. These and other projects that address how humans and the environment interact are the focus of $21 million in National Science Foundation (NSF) grants to scientists, engineers and educators across the country to study coupled natural and human systems. Research conducted through NSF's Dynamics of Cou( read more).....
Molecular structure of retrovirus enzyme solved through On-line Gamers Succeed Where Scientists Fail, Opening Door to New AIDS Drug Design
Molecular structure of retrovirus enzyme solved through "Foldit" Online gamers have solved the structure of a retrovirus enzyme whose configuration had stymied scientists. The players were adept at a computer game, Foldit, that allows players to collaborate and compete in predicting the structure of protein molecules. After scientists repeatedly failed to piece together the structure of a protein-cutting enzyme from an AIDS-like virus, they called in the Foldit players. The scientists ( read more).....
WASHINGTON - The U.S. Environmental Protection Agency (EPA) will hold three public hearings in September on the agency's proposed standards to reduce air pollution from oil and gas drilling operations. The proposed standards would rely on cost-effective, existing technologies and practices to reduce pollution that contributes to smog and can cause cancer, while supporting the administration's priority of continuing to expand safe and responsible domestic oil and natural gas production. WHAT: Public hearings on proposed air pollution standards for the oil and natural gas industry WHEN: Sept EPA to Hold Three Public Hearings on Proposed Air Pollution Standards for Oil and Natural Gas Production
WASHINGTON - The U.S. Environmental Protection Agency (EPA) will hold three public hearings in September on the agency's proposed standards to reduce air pollution from oil and gas drilling operations. The proposed standards would rely on cost-effective, existing technologies and practices to reduce pollution that contributes to smog and can cause cancer, while supporting the administration's priority of continuing to expand safe and responsible domestic oil and natural gas production. WHAT: Pu( read more).....
On September 19, 2011, on the margins of the United Nations General Assembly in New York City, the Government of the United States of America and the World Health Organization (WHO) signed a memorandum of understanding (MOU) to help developing nations strengthen their capabilities to support the International Health Regulations (IHR). The IHR (2005) is an international agreement that requires WHO Member States to prevent and respond to acute public health risks that have the potential to cross borders and threaten people worldwide. The U.S. Government and the WHO share a commitment to s U.S. Government and World Health Organization sign agreement to help developing countries strengthen their capabilities to meet International Health Regulations
On September 19, 2011, on the margins of the United Nations General Assembly in New York City, the Government of the United States of America and the World Health Organization (WHO) signed a memorandum of understanding (MOU) to help developing nations strengthen their capabilities to support the International Health Regulations (IHR). The IHR (2005) is an international agreement that requires WHO Member States to prevent and respond to acute public health risks that have the potential to cro( read more).....
While the use of internally cured concrete in construction is not new, there is now better understanding of the internal curing process and why IC using pre-wetted lightweight aggregate increases concrete durability and service life in an economical and practical way. However, there is not currently a standard for lightweight aggregates for internal curing. ASTM International Committee C09 on Concrete and Concrete Aggregates is now developing such a proposed standard, ASTM WK34078, Specification for Lightweight Aggregate for Internal Curing of Concrete. The proposed standard is under the ju ASTM Concrete Committee at Work on Proposed Lightweight Aggregates Standard
While the use of internally cured concrete in construction is not new, there is now better understanding of the internal curing process and why IC using pre-wetted lightweight aggregate increases concrete durability and service life in an economical and practical way. However, there is not currently a standard for lightweight aggregates for internal curing. ASTM International Committee C09 on Concrete and Concrete Aggregates is now developing such a proposed standard, ASTM WK34078, Specificat( read more).....
ASTM International Committee E35 on Pesticides, Antimicrobials and Alternative Control Methods invites all interested parties to join a new task group on biorationals. The task group is under the jurisdiction of Subcommittee E35.22 on Pesticide Formulations and Delivery Systems. The primary purpose of the task group will be to define products being marketed as biorationals. In response to ever-increasing demands for production of food and fiber, the growth in nontraditional pest control agents based on biologically derived materials continues to grow as well. Several terms are being propose Biorationals Are The Subject of a New Task Group in ASTM Pesticides Committee
ASTM International Committee E35 on Pesticides, Antimicrobials and Alternative Control Methods invites all interested parties to join a new task group on biorationals. The task group is under the jurisdiction of Subcommittee E35.22 on Pesticide Formulations and Delivery Systems. The primary purpose of the task group will be to define products being marketed as biorationals. In response to ever-increasing demands for production of food and fiber, the growth in nontraditional pest control agent( read more).....
The need for a consensus standard targeting the measurement of gaseous hydrocarbons and other components of gaseous streams allowing users to better comply with U.S. Environmental Protection Agency's greenhouse gas regulation provided the impetus for the development of a proposed new ASTM International standard meeting this need. ASTM WK33788, Test Method for Determination of Hydrocarbons and Nonhydrocarbon Gases in Gaseous Mixtures by Gas Chromatography, is under development by Subcommittee D03.07 on Analysis of Chemical Composition of Gaseous Fuels, part of ASTM International Committee D0 Proposed ASTM Standard Facilitating Compliance with Greenhouse Gas Regulations
The need for a consensus standard targeting the measurement of gaseous hydrocarbons and other components of gaseous streams allowing users to better comply with U.S. Environmental Protection Agency's greenhouse gas regulation provided the impetus for the development of a proposed new ASTM International standard meeting this need. ASTM WK33788, Test Method for Determination of Hydrocarbons and Nonhydrocarbon Gases in Gaseous Mixtures by Gas Chromatography, is under development by Subcommittee ( read more).....
A new ASTM guide standardizes a useful, fast and easy technique for collecting infrared spectra of non-aqueous liquid paints right out of the can. The new standard, ASTM D7588, Guide for FT-IR Fingerprinting of a Non-Aqueous Liquid Paint as Supplied in the Manufacturer's Container, is under the jurisdiction of Subcommittee D01.21 on Chemical Analysis of Paints and Paint Materials, which is part of ASTM International Committee D01 on Paint and Related Coatings, Materials and Applications. New ASTM Paint Guide Standardizes Methods of Infrared Spectra Collection
A new ASTM guide standardizes a useful, fast and easy technique for collecting infrared spectra of non-aqueous liquid paints right out of the can. The new standard, ASTM D7588, Guide for FT-IR Fingerprinting of a Non-Aqueous Liquid Paint as Supplied in the Manufacturer's Container, is under the jurisdiction of Subcommittee D01.21 on Chemical Analysis of Paints and Paint Materials, which is part of ASTM International Committee D01 on Paint and Related Coatings, Materials and Applications. "Th( read more).....
Manufacturers of solar radiometers and testing laboratories for solar energy, materials and durability testing will be among the primary users of a new ASTM International standard that outlines procedures using indoor test methods to calibrate radiometers with dissimilar detectors. The new standard, ASTM G207, Test Method for Indoor Transfer of Calibration from Reference to Field Pyranometers, was developed by Subcommittee G03.09 on Radiometry, part of ASTM International Committee G03 on Weathering and Durability. ASTM G207 facilitates calibration of solar sensors used in accelerated testin Calibration of Radiometers Is Covered in New ASTM Weathering and Durability Standard
Manufacturers of solar radiometers and testing laboratories for solar energy, materials and durability testing will be among the primary users of a new ASTM International standard that outlines procedures using indoor test methods to calibrate radiometers with dissimilar detectors. The new standard, ASTM G207, Test Method for Indoor Transfer of Calibration from Reference to Field Pyranometers, was developed by Subcommittee G03.09 on Radiometry, part of ASTM International Committee G03 on Weat( read more).....
A new ASTM InCalibration of Radiometers Is Covered in New ASTM Weathering and Durability Standard ternational standard provides a more detailed and complete description of a test protocol that has been used for more than 40 years in code requirements and specifications for fire-retardant-treated wood. This test is now also used in some codes for building products that are not wood. The new standard, ASTM E2768, Test Method for Extended Duration Surface Burning Characteristics of Building Materials (30 Min. Tunnel Test), was developed by Subcommittee E05.22 on Surface Burning, part of AST New ASTM Fire Standard Provides Detailed Description of Extended Duration Surface Burning Characteristics
A new ASTM InCalibration of Radiometers Is Covered in New ASTM Weathering and Durability Standard ternational standard provides a more detailed and complete description of a test protocol that has been used for more than 40 years in code requirements and specifications for fire-retardant-treated wood. This test is now also used in some codes for building products that are not wood. The new standard, ASTM E2768, Test Method for Extended Duration Surface Burning Characteristics of Building M( read more).....
BARDA contracts will expand the tools available to protect the nation in a bioterrorism attack The advanced development of a novel next-generation anthrax vaccine and a new type of anthrax antitoxin have received support through new contracts funded the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). Vaccines prevent illness by boosting the body's ability to make antibodies so the body recognizes and eliminates a bacteria or virus; with antitoxins, antibodies are injected directly into the body to neutralize the bacteria or vi Novel anthrax vaccine and antitoxin being developed with federal support
BARDA contracts will expand the tools available to protect the nation in a bioterrorism attack The advanced development of a novel next-generation anthrax vaccine and a new type of anthrax antitoxin have received support through new contracts funded the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). Vaccines prevent illness by boosting the body's ability to make antibodies so the body recognizes and eliminates a bacteria or vir( read more).....
The U.S. Food and Drug Administration (FDA) announced today a streamlined, integrated approach to effectively and rapidly respond to human and animal foodborne illness outbreaks: the FDA Coordinated Outbreak Response and Evaluation (CORE) Network. The CORE Network is comprised of a multi-disciplinary team of epidemiologists, veterinarians, microbiologists, environmental health specialists, emergency coordinators, and risk communications specialists. Working full-time on outbreak prevention and response at headquarters, the CORE is complemented by trained, experienced investigators in FDA fi US Food and Drug Adminsitration US FDA establishes foodborne illness outbreak response network Aims at increased coordination, using lessons learned
The U.S. Food and Drug Administration (FDA) announced today a streamlined, integrated approach to effectively and rapidly respond to human and animal foodborne illness outbreaks: the FDA Coordinated Outbreak Response and Evaluation (CORE) Network. The CORE Network is comprised of a multi-disciplinary team of epidemiologists, veterinarians, microbiologists, environmental health specialists, emergency coordinators, and risk communications specialists. Working full-time on outbreak prevention an( read more).....
The U.S. Food and Drug Administration announced today that two Minnesota companies have agreed to halt distribution of amino-acid products marketed to treat a number of diseases, until requirements of the Federal Food, Drug, and Cosmetic Act are met. West Duluth Distribution Co., a corporation doing business as CHK Nutrition, and NeuroResearch Clinics Inc., both of Duluth, Minn., and their owners or principals, signed a consent decree of permanent injunction, which was entered by the U.S. District Court for the District of Minnesota on September 13. The complaint for permanent injunction US Food and Drug Administration US FDA Minnesota companies agree to halt sale of amino-acid products with unapproved claims Websites touted products as cure or treatment for diseases
The U.S. Food and Drug Administration announced today that two Minnesota companies have agreed to halt distribution of amino-acid products marketed to treat a number of diseases, until requirements of the Federal Food, Drug, and Cosmetic Act are met. West Duluth Distribution Co., a corporation doing business as CHK Nutrition, and NeuroResearch Clinics Inc., both of Duluth, Minn., and their owners or principals, signed a consent decree of permanent injunction, which was entered by the U.S. Dis( read more).....
Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research's (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP). US Food and Drug Administration US FDA announces changes in drug center's oncology office Review divisions to be aligned by expertise, disease-specific areas
Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research's (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP). "Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements( read more).....
The U.S. Food and Drug Administration today said that two new pilot projects will enhance the agency's and industry's ability to trace products responsible for foodborne illness outbreaks. The Institute of Food Technologists (IFT), a nonprofit scientific society consisting of professionals engaged in food science, food technology, and related professions, will carry out the pilots at the direction of FDA, under an existing FDA contract. The Food Safety Modernization Act requires the FDA to establish at least two pilot projects: one involving produce and one involving processed foods. Sig US Food and Drug Administration US FDA Pilot projects to explore ways to trace sources of foodborne illness Required under Food Safety Modernization Act
The U.S. Food and Drug Administration today said that two new pilot projects will enhance the agency's and industry's ability to trace products responsible for foodborne illness outbreaks. The Institute of Food Technologists (IFT), a nonprofit scientific society consisting of professionals engaged in food science, food technology, and related professions, will carry out the pilots at the direction of FDA, under an existing FDA contract. The Food Safety Modernization Act requires the FDA to( read more).....
Frederick, Maryland, Sept 7, 2011 The course is intended for students who already understand the basics of measurement uncertainty estimation, either from classroom experience or self-education. Although the class is designed for personnel working in accredited calibration and testing laboratories, anyone working in calibration, metrology, testing, or other measurement fields should find the class beneficial. After attending the course, students should be able to confidently perform measurement uncertainty calculations that meet their needs and satisfy accreditation requirements. Topics The American Association for Laboratory Accreditation (A2LA) is now offering on-site Advanced Measurement Uncertainty training at your facility.
Frederick, Maryland, Sept 7, 2011 The course is intended for students who already understand the basics of measurement uncertainty estimation, either from classroom experience or self-education. Although the class is designed for personnel working in accredited calibration and testing laboratories, anyone working in calibration, metrology, testing, or other measurement fields should find the class beneficial. After attending the course, students should be able to confidently perform measurem( read more).....
ASTM Proficiency Testing Programs (PTP) are statistical quality assurance programs that enable laboratories to assess their performance in conducting test methods within their own laboratories when their data are compared against other laboratories that participate worldwide in the same program. ASTM Proficiency Testing Programs on Textiles are sponsored by ASTM Committee D13 on Textiles. The two programs, Textiles (Light, Medium and Heavy-Duty Woven Fabric), and Yarn and Thread Performance Testing, provide participating laboratories with a statistical quality assurance (SQA) tool to improv ASTM International Proficiency Testing Programs on Textiles
ASTM Proficiency Testing Programs (PTP) are statistical quality assurance programs that enable laboratories to assess their performance in conducting test methods within their own laboratories when their data are compared against other laboratories that participate worldwide in the same program. ASTM Proficiency Testing Programs on Textiles are sponsored by ASTM Committee D13 on Textiles. The two programs, Textiles (Light, Medium and Heavy-Duty Woven Fabric), and Yarn and Thread Performance T( read more).....
The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH's Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, will launch this month and is intended to include all new device reviewers. The program includes up to 18 months of training, aimed at comple US Food and Drug Administration US FDA announces new staff training for medical device reviewers Training a key step to improving device review program, strategic priorities
The U.S. Food and Drug Administration today announced two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH). The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH's Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, will launch this month and is intended to in( read more).....
Since day one, under President Obama's leadership, EPA has worked to ensure health protections for the American people, and has made tremendous progress to ensure that Clean Air Act standards protect all Americans by reducing our exposures to harmful air pollution like mercury, arsenic and carbon dioxide. This Administration has put in place some of the most important standards and safeguards for clean air in U.S. history: the most significant reduction of sulfur dioxide and nitrogen oxide air pollution across state borders; a long-overdue proposal to finally cut mercury pollution from power Statement by EPA Administrator Lisa P. Jackson on the Ozone National Ambient Air Quality Standards
Since day one, under President Obama's leadership, EPA has worked to ensure health protections for the American people, and has made tremendous progress to ensure that Clean Air Act standards protect all Americans by reducing our exposures to harmful air pollution like mercury, arsenic and carbon dioxide. This Administration has put in place some of the most important standards and safeguards for clean air in U.S. history: the most significant reduction of sulfur dioxide and nitrogen oxide air ( read more).....
Ten years after the tragic events of September 11, 2001, staff at RJ Lee Group who were involved in assessing the environmental aftermath of the collapse of the Twin Towers reflected on their participation. Reflections on the 10th Anniversary of the 9/11 Tragedy
Ten years after the tragic events of September 11, 2001, staff at RJ Lee Group who were involved in assessing the environmental aftermath of the collapse of the Twin Towers reflected on their participation. "We needed the objectivity to perform the scientific tasks at hand, but our hearts were so full of emotion we struggled every day to reach that goal," related Dr. Richard J. Lee, President and CEO of RJ Lee Group, Inc. "Those who participated in the collection, processing, and analysis of sam( read more).....
(MONROEVILLE, Pennsylvania - August 24, 2011) Dr. Kristin Bunker, Senior Scientist at RJ Lee Group, Inc. joins the team at 113 Industries as a Scientific Advisor. 113 Industries is a consulting company whose mission is to help clients convert new discoveries and technologies into viable products. In her role as scientific advisor, Dr. Bunker will offer her technical opinion and expertise in materials science and specifically in the semiconductor and life sciences sectors. Her current work at RJ Lee Group focuses on nanotechnology and the characterization and environmental impact of nanomateria RJ Lee Group's Dr. Kristin Bunker Teams with 113 Industries as Scientific Advisor
(MONROEVILLE, Pennsylvania - August 24, 2011) Dr. Kristin Bunker, Senior Scientist at RJ Lee Group, Inc. joins the team at 113 Industries as a Scientific Advisor. 113 Industries is a consulting company whose mission is to help clients convert new discoveries and technologies into viable products. In her role as scientific advisor, Dr. Bunker will offer her technical opinion and expertise in materials science and specifically in the semiconductor and life sciences sectors. Her current work at RJ ( read more).....
Micro Quality Labs is now an ISO accredited laboratory in accordance with the recognized International Standard ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories. This accreditation demonstrates technical competence for the operation of a laboratory quality management system. Micro Quality Labs was recently awarded ISO 17025 Certification!
Micro Quality Labs is now an ISO accredited laboratory in accordance with the recognized International Standard ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories. This accreditation demonstrates technical competence for the operation of a laboratory quality management system.( read more).....
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year. This ALK gene abnormality causes cancer development and growth. About US Food and Drug Adminsitration FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer Second targeted therapy approved with a test this year
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy appr( read more).....
US Food and Drug Administration US FDA: U.S. Marshals seize food products held at North Carolina warehouse FDA acts to prevent distribution of food from rodent-infested facility At the request of the U.S. Food and Drug Administration, U.S. Marshals seized all FDA-regulated food susceptible to rodent and pest contamination or other filth held at the Durham, North Carolina, warehouse of CFSD, Inc., which does business as Chan's Food Service. The products were seized under a warrant issued by the U.S. District Court for the Middle District of North Carolina. According to the governmen US Food and Drug Administration US FDA: U.S. Marshals seize food products held at North Carolina warehouse FDA acts to prevent distribution of food from rodent-infested facility year
US Food and Drug Administration US FDA: U.S. Marshals seize food products held at North Carolina warehouse FDA acts to prevent distribution of food from rodent-infested facility At the request of the U.S. Food and Drug Administration, U.S. Marshals seized all FDA-regulated food susceptible to rodent and pest contamination or other filth held at the Durham, North Carolina, warehouse of CFSD, Inc., which does business as Chan's Food Service. The products were seized under a warrant issued by( read more).....
At the request of the U.S. Food and Drug Administration, U.S. Marshals, yesterday, seized seafood products manufactured by the Meiko Food Co., South El Monte, Calif., because the products are adulterated. A complaint, filed in the U.S. District Court for the Central District of California, alleges that Meiko Foods manufactures and packages ready-to-eat seafood, including cooked seafood balls and fried fish cakes, without having a Hazard Analysis Critical Control Point (HACCP) plan in place, in violation of the Federal Food, Drug, and Cosmetic Act. The HACCP program is a science-based sys US Food and Drug Administration US FDA requests seizure of adulterated seafood at California company Meiko Food allegedly fails to have a required preventive control plan for seafood products
At the request of the U.S. Food and Drug Administration, U.S. Marshals, yesterday, seized seafood products manufactured by the Meiko Food Co., South El Monte, Calif., because the products are adulterated. A complaint, filed in the U.S. District Court for the Central District of California, alleges that Meiko Foods manufactures and packages ready-to-eat seafood, including cooked seafood balls and fried fish cakes, without having a Hazard Analysis Critical Control Point (HACCP) plan in place, i( read more).....
The U.S. Food and Drug Administration US FDA today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older. HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal US Food and Drug Administration US FDA approves Firazyr to treat acute attacks of hereditary angioedema
The U.S. Food and Drug Administration US FDA today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older. HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States( read more).....
The U.S. Food and Drug Administration US FDA today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder. Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder. The treatment consists of Botox being injected into the bladder resulting in rela US Food and Drug Administration US FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration US FDA today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder. Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empt( read more).....

 
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International Regulatory News

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers
2011-12-12 00:00:00
The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to ... 

Trident catheter valve - Model Number: 380851
2011-12-12 00:00:00
The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary cath... 

TGA reforms: a blueprint for TGA's future
2011-12-08 00:00:00
Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undert... 

Respirtek ISO 17025 Business Management Improvements
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

Respirtek, Inc. ISO 17025 Accreditation Announcement
2011-11-22 00:00:00
After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients wel... 

UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update
2011-11-11 00:00:00
The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, wher... 

ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE
2011-11-08 00:00:00
A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving... 

Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry
2011-11-01 00:00:00
Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of ... 

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation
2011-10-26 00:00:00
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgeto... 


2011-10-26 00:00:00
FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tabl... 

FDA approves Onfi to treat severe type of seizures
2011-10-26 00:00:00
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended t... 

Illinois warehouse Prevents unsafe food distribution from rodent-infested facility
2011-10-19 00:00:00
FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warr... 

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