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By Ronald A. Rader, Biotechnology Information Institute
Published September 5, 2013
Citizen petition requests biopharmaceutical names and information be disclosed by FDA Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
Published July 13, 2011
Chartwell Pharmaceuticals is now a registered pharmaceutical manufacturer with the FDA, effective March 15, 2011. Read More »
Published May 25, 2010
The FDA has finalized the terms of the consent decree regarding Genzyme’s Allston manufacturing plant, subject to approval by the U.S. District Court for the District of Massachusetts. Read More »
Published March 25, 2010
The FDA has notified Genzyme Corp. that it intends to take enforcement action to ensure that products manufactured at the company’s Allston plant are made in compliance with GMP regulations. Read More »
Published March 24, 2010
Belgian site to produce lyophilized cytotoxic cancer treatment Read More »
Published November 17, 2008
The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval… Read More »
Published September 14, 2007
Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiat… Read More »
Published May 23, 2007
Draxis Pharma, the CMO division of Draxis Health Inc., recently received word from the FDA that its Montreal facilities passed inspection. FDA conducted inspections of all six production and quality systems at Draxis Pharma in January 2007. The inspe… Read More »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production Read More »
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