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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 »
By Kristin Brooks
Published January 24, 2014
Prohibits manufacture and sale of drug ingredients from Toansa plant Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production 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 Gary C. Messplay, J.D., Allison L. Reschovsky, J.D., and Adele M. Kaplan Gilpin, J.D., Ph.D., Hunton & Williams LLP
Published May 30, 2012
A new era of clinical trial transparency enforcement 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 John Avellanet
Published September 7, 2011
Where is the FDA headed? Read More »
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