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View Regulatory RequestsInternational Regulatory News
New CLSI Guideline Addresses Quality Control for Commercial Microbial Identification Systems
2008-02-11 00:00:00
Wayne, Pennsylvania, USA-February 2008-Microbial identification systems (MISs) are test
systems that utilize multiple substrates and/or reagents to i...
CLSI Publishes Protocol for the Evaluation, Validation,and Implementation of Coagulometers
2008-02-11 00:00:00
Wayne, Pennsylvania, USA-February 2008-Coagulometers are used in clinical laboratories for
the common screening tests including prothrombin time, act...
CLSI Publishes Guideline for the Collection, Transport,and Processing of Blood Specimens for Coagulation Assays
2008-02-11 00:00:00
Wayne, Pennsylvania, USA-February 2008-The reliability and accuracy of coagulation test
results depend upon a variety of variables, including anticoa...
CLSI Publishes Guideline for Evaluation of Qualitative Test Performance
2008-02-11 00:00:00
Wayne, Pennsylvania, USA¡XFebruary 2008¡XQualitative diagnostic tests have been used since the early days of laboratory medicine for the screening, di...
CLSI Awarded Contract to Improve Laboratory Practices in Mali
2008-02-11 00:00:00
Wayne, Pennsylvania, USA-February 2008-Global standards-development organization Clinical
and Laboratory Standards Institute (CLSI, formerly NCCLS) h...
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
2008-02-11 00:00:00
FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified
The U.S. Food and Drug Administration anno...
FDA Notifies Public of Adverse Reactions Linked to Botox Use
2008-02-08 00:00:00
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking place
The U.S. Food and Drug Administration today notified the public that Botox ...
FDA Clears for Market First Decellularized Heart Valve
2008-02-07 00:00:00
The U.S. Food and Drug Administration today cleared for marketing the first replacement heart valve from donated human tissue in which the cells have ...
New Era Canning Company Expands Nationwide Recall
2008-02-07 00:00:00
Risk of botulism from additional canned vegetable products
The U.S. Food and Drug Administration (FDA) is alerting consumers, food service operato...
FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine
2008-02-06 00:00:00
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colch...
FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food
2008-02-06 00:00:00
Contaminated pet food caused pet illnesses and deaths last year
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations ann...
Generic Fosamax Approved
2008-02-06 00:00:00
The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a...
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