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April 30, 2008
Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.
April 16, 2008
The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.
February 28, 2008
The US Food and Drug Administration released a final guidance on protocol for testing sterile products.
October 11, 2007
The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.
September 13, 2007
The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.
July 12, 2007
A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.
June 07, 2007
Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).
Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.
May 03, 2007
Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.
October 25, 2006
The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.