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By Ed Silverman, Contributing Editor
Published November 13, 2013
Can FDA get tough? 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 »
Published July 13, 2009
The FDA has approved the NDA by Daiichi Sankyo and Eli Lilly and Co. for Effient (prasugrel) tablets 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 October 17, 2008
Catalent Pharma Solutions received notice that the FDA has approved the sale of a prescription product manufactured at its recently opened pre-filled syringe facility in Brussels, Belgium. Syringes from the Brussels facility will likely be dispensed… Read More »
Published February 27, 2008
The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.     The plan, first reported by the Wall Street Journal and… Read More »
Published July 6, 2006
The Association of Clinical Research Organizations (ACRO) and the FDA have announced a new initiative to modernize the clinical trial process with the formation of a collaborative group to support the development of data collection standards for regu… 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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