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By Kristin Brooks
Published January 24, 2014
Prohibits manufacture and sale of drug ingredients from Toansa plant Read More »
By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
By Kristin Brooks
Published January 2, 2014
Phase II Tosedostat trials in blood cancer resume Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
By Gil Roth
Published December 2, 2013
AcelRx pain management system to be reviewed Read More »
Published December 2, 2013
Regensburg site to manufacture four solid and semi-solid, high-potent products 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 Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
Published February 27, 2012
Application submitted for an already approved NDA for any changes in packaging, labeling, dosages, ingredients or new indications.… 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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