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By Kristin Brooks
Published January 2, 2014
Phase II Tosedostat trials in blood cancer resume Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
Published December 2, 2013
Regensburg site to manufacture four solid and semi-solid, high-potent products Read More »
Published October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published February 27, 2012
An FDA-approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA. By designating a single RLD as the 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 »
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