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Published April 3, 2014
Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act Read More »
Published November 25, 2013
Will be added to the national stockpile Read More »
By Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
Published January 22, 2013
FDA revises draft guidance document to address industry comments Read More »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
Published June 15, 2011
Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA. Read More »
Published June 28, 2007
SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing… Read More »
Published June 25, 2007
Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made throu… 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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