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By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit 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 October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments 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 »
By Heather D. Bau00f1uelos
Published July 13, 2011
A busy year for the agency Read More »
By Stephen Barlas
Published February 15, 2011
Confusion, anxiety reign as Agency talks tagging Read More »
Trends in 505(b)(2) Approvals
By Loren Gelber
Published March 3, 2010
The who, what, why, when and how of this hybrid application process Read More »
By Gary C. Messplay and Colleen Heisey
Published January 22, 2009
New document covers principles and practices guiding process validation Read More »

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