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Published April 30, 2014
Analytical and stability testing, and CTM services deemed compliant 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 »
Published February 19, 2014
13 prequalified companies will participate in program to enhance security of imported drugs Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
By Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
Published March 7, 2012
New guidance seeks to clear up manufacturer communications 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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