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By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
Published December 3, 2013
Prepares for commercial launch of BTG’s Varithena Read More »
Published December 2, 2013
Regensburg site to manufacture four solid and semi-solid, high-potent products Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations 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 »
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
An FDA-approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the RLD in its ANDA. By designating a single RLD as the standard… Read More »
Trends in 505(b)(2) Approvals
By Loren Gelber
Published March 3, 2010
The who, what, why, when and how of this hybrid application process 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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