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Setting Up an FDA-Compliant Data Integrity Program
By John Avellanet, Cerulean Associates LLC
Published October 1, 2014
(What’s So Funny ‘Bout) Part 11 and Data Integrity Read More »
Published June 10, 2014
One Spray per Device, Without the Need for Priming, Provides Greater Ease of Use Read More »
Published April 24, 2014
Employs Novozymes' VELTIS technology for optimized dosing Read More »
FDA’s Friedman on Reliable Manufacturing, From Interphex 2014
By Agnes Shanley, Editor
Published March 20, 2014
At the PDA conference track at Interphex 2014 in New York City, Richard Friedman, Associate Director of FDA’s Office of Manufacturing & Product Quality, discussed what differentiates reliable from unreliable aseptic processes. Read More »
By Kristin Brooks
Published March 6, 2014
Will produce PLacental eXpanded (PLX) cell products Read More »
Published February 19, 2014
13 prequalified companies will participate in program to enhance security of imported drugs Read More »
High Potency Regulations
By Stephanie Wilkins, PharmaConsult US, Inc.
Published November 13, 2013
Uncertainty remains in the quest to define certain products Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
By Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »


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