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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 »
By Gil Roth
Published December 9, 2013
Helsinn, Eisai file for netupitant, palonosetron combo Read More »
Published December 2, 2013
Regensburg site to manufacture four solid and semi-solid, high-potent products Read More »
Labeling on Ferrules and Cap Overseals
By Carol Mooney, West Pharmaceutical Services, Inc.
Published May 6, 2013
What drugmakers need to know about the Revised USP General Chapter <1> Injections Standard 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 Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
FDA Expectations for Parenteral Supplier Controls
By John Avellanet
Published November 10, 2010
Does a device guidance hold the key? 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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