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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 November 14, 2012
2010 warning letter sited nine issues Read More »
Published September 26, 2012
Will conduct bioequivalence clinical studies Read More »
By Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
Published March 7, 2012
New guidance seeks to clear up manufacturer communications Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
By Heather D. Bau00f1uelos
Published July 13, 2011
A busy year for the agency Read More »
Published March 3, 2011
Lyophilization Services of New England, Inc. (LSNE) has recently completed a comprehensive FDA audit of its medical device manufacturing facility in Manchester, NH. 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 »
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