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Published June 10, 2014
One Spray per Device, Without the Need for Priming, Provides Greater Ease of Use 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 »
By Kristin Brooks
Published January 24, 2014
Prohibits manufacture and sale of drug ingredients from Toansa plant Read More »
By Kristin Brooks
Published January 2, 2014
Phase II Tosedostat trials in blood cancer resume Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
Biosimilars, the FDA, and the Supreme Court
By Elizabeth Spar and Tom Wintner, Edwards Wildman Palmer LLP
Published September 6, 2012
Challenges for innovators and biosimilar applicants 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 »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »


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