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Published July 8, 2014
Gains certification by Belgium and EU authorities Read More »
Published May 6, 2014
Cytovance to manufacture SELK2 drug product Read More »
Published April 3, 2014
Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act Read More »
Going Beyond cGMP: Good for Business
By Gerard Creaner, Get Reskilled
Published March 7, 2014
Take a meaningful step to build a quality culture — from the shop floor up. Read More »
By Heather Banuelos, Hunton & Williams LLP
Published May 6, 2013
DOJ to pursue enforcement Read More »
Published January 14, 2013
Becomes first CRO with ion channel cGMP testing capability Read More »
Published February 27, 2012
Current accepted standards of design, operation, practice and sanitization. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged and stored for compliance with these standards. See also Good M… Read More »
By Gary Messplay and Colleen Heisey
Published November 6, 2008
FDA updates its rules on current Good Manufacturing Practices Read More »
Published May 9, 2014
Will provide early stage preclinical to commercial production Read More »
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 »
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