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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 »
Published February 27, 2012
Application submitted for an already approved NDA for any changes in packaging, labeling, dosages, ingredients or new indications.… Read More »
Published September 13, 2011
Facility is fully validated for manufacture of injectable sterile products 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 »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate 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 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 »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »


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