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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 Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »
By Gil Roth
Published February 5, 2014
First-year goals met 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 »
By Steve Snyder
Published October 8, 2010
An FDA ruling stuns the industry Read More »
Risk Management in the Biomaterial Cold Chain
By Jeff Clark
Published November 3, 2006
Mitigating risks & ensuring compliance Read More »
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