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By Gil Roth
Published December 20, 2013
BMS, Pfizer seek new indications against DVT, PE Read More »
Published November 5, 2013
Resolves all issues at Burlington facility Read More »
By Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
By Gil Roth
Published October 30, 2013
MannKind tries again with inhaled insulin Read More »
Published June 26, 2013
Wolfratshausen facility supports dosage forms for U.S. distribution Read More »
By Gil Roth
Published July 31, 2012
No 483s at Clinical Pharmacology Unit Read More »
Published August 19, 2009
Catalent's softgel facility in Buenos Aires successfully completed its first FDA cGMP audit and PAI 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 February 27, 2008
The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.     The plan, first reported by the Wall Street Journal and… 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 »
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