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By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
By Gil Roth
Published January 8, 2014
Natpara action date October 2014 for hypoparathyroidism indication Read More »
By Kristin Brooks
Published January 2, 2014
Phase II Tosedostat trials in blood cancer resume Read More »
By Kristin Brooks
Published December 17, 2013
IA site GMP compliant, with no Form 483 observations Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
Biosimilars, the FDA, and the Supreme Court
By Elizabeth Spar and Tom Wintner, Edwards Wildman Palmer LLP
Published September 6, 2012
Challenges for innovators and biosimilar applicants 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 »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »
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