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By Kristin Brooks
Published December 17, 2013
IA site GMP compliant, with no Form 483 observations Read More »
By Gil Roth
Published December 2, 2013
AcelRx pain management system to be reviewed Read More »
By Ed Silverman, Contributing Editor
Published November 13, 2013
Can FDA get tough? Read More »
Labeling on Ferrules and Cap Overseals
By Carol Mooney, West Pharmaceutical Services, Inc.
Published May 6, 2013
What drugmakers need to know about the Revised USP General Chapter <1> Injections Standard Read More »
By Gil Roth
Published July 31, 2012
No 483s at Clinical Pharmacology Unit Read More »
Published March 24, 2010
Belgian site to produce lyophilized cytotoxic cancer treatment Read More »
Published January 19, 2009
Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal wome… Read More »
Published August 25, 2008
The FDA has approved Amgen's Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA… 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 »
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