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By Gil Roth
Published January 8, 2014
Natpara action date October 2014 for hypoparathyroidism indication Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations Read More »
Labeling on Ferrules and Cap Overseals
By Carol Mooney, West Pharmaceutical Services, Inc.
Published May 6, 2013
What drugmakers need to know about the Revised USP General Chapter <1> Injections Standard Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March Read More »
Published October 6, 2011
Vadodara site can now provide API manufacturing Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
Responding to a WARNING LETTER
By Shamik Pandit
Published April 30, 2008
Part 2 of 2 on what to do when the FDA sends you a letter Read More »


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