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Published July 22, 2014
Will produce NME for U.S. market Read More »
FDA Aseptic Inspections Will Focus on Process, FDA’s Friedman Says
Published March 27, 2014
At a PDA conference track at Interphex 2014, FDA’s Richard Friedman, Associate DirectorAssociate Director of FDA’s Office of Manufacturing and Product Quality at the Center for Drug Evaluation and Research’s Office of Compliance, discussed changes in the way FDA inspectors will review aseptic facilities. The emphasis now, he says, will be on day to day process operations and control. Read More »
By Ed Silverman, Contributing Editor
Published November 13, 2013
Can FDA get tough? Read More »
Published October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
Global API Inspections
By Tony Scott, European Fine Chemicals Group
Published January 22, 2013
Can Mutual Recognition Agreements ensure safety? Read More »
Are You Gambling With Your Next Inspection?
By Julie Larsen, BioTeknica, Inc.
Published November 9, 2012
10 Key Questions to Assess Inspection Readiness 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 »
Mitigating the Challenges Of Global Trials
By Todd Kole and Joseph Bedford, Almac
Published November 9, 2012
e-Clinical best practices for managing patients and clinical supplies in emerging regions Read More »
Newsmakers: Clive Bennett
By Gil Y. Roth, Contract Pharma
Published May 30, 2012
Halo CEO Clive Bennett Read More »
IT Focus: Computer System Validation
By Michael J. Gregor
Published March 3, 2010
Prepare your systems for FDA inspection Read More »
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