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By Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
Published March 28, 2013
RVW provides cold storage and visual inspection Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
Published February 13, 2012
No 483 observations issued Read More »
By Gil Roth
Published January 17, 2012
Elder leaves agency after more than two decades Read More »
Published August 19, 2011
Joint inspection focused on increasing international regulatory collaboration Read More »
Published August 12, 2011
To manufacture a solid dose product for a client 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 »
Published January 2, 2007
Ranbaxy Laboratories has received approval from the FDA to manufacture and market Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg. The Office of Generic Drugs, U.S. FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same the… Read More »
Published June 7, 2006
Pharsight Corp., a provider of software and services for clinical drug development, has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER). Under the terms of the CRA… Read More »


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