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By Sheldon Bradshaw & Sharon Bradley, Hunton & Williams LLP
Published January 24, 2014
In direct response to the 2012 deadly fungal meningitis outbreak that was linked to unsanitary conditions at a compounding pharmacy, Congress recently passed the Drug Quality and Security Act (DQSA), which, among other things, amended Section 503A of… Read More »
By Ronald A. Rader, Biotechnology Information Institute
Published September 5, 2013
Citizen petition requests biopharmaceutical names and information be disclosed by FDA Read More »
Critical Design Strategies for Extractables and Leachables Control
By Thomas Feinberg, Catalent Pharma Solutions
Published April 3, 2013
Methods for avoiding contamination Read More »
By Gil Roth
Published July 5, 2012
Coating Place to supply patent-protected API Read More »
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Published August 11, 2011
Actions implemented at the site addressed manufacturing issues Read More »
FDA Expectations for Parenteral Supplier Controls
By John Avellanet
Published November 10, 2010
Does a device guidance hold the key? Read More »
Published November 17, 2008
The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval… Read More »
Published September 14, 2007
Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiat… 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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