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Risk and Quality Management: Connecting the Dots
By Bikash Chatterjee , President and CTO, Pharmatech
Published September 8, 2014
A brief review of pharma’s new thinking regarding quality and risk management, and key risk management tools Read More »
Strange Ally in the War Against Sepsis
By Agnes Shanley , Editor
Published September 8, 2014
50 years ago this year, scientists first connected an ancient sea creature to testing for life-threatening bacteria Read More »
Published October 3, 2013
Successfully passes 12 inspections in 18 months Read More »
By Mak Jawadekar, Contributing Editor
Published June 5, 2013
There has been plenty of buzz these days in pharma supply chain conferences about serialization and electronic pedigree systems. The U.S. Congress has again started discussing development of a nationwide Track & Trace (T&T) system for pharma… Read More »
By Heather Banuelos, Hunton & Williams LLP
Published May 6, 2013
DOJ to pursue enforcement Read More »
Generic Manufacturing: GDUFA & CMOs
By Gil Y. Roth, Contract Pharma
Published March 6, 2013
Generic facility fees cause sticker shock Read More »
By Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
Published November 9, 2012
Self-identification under the Generic Drug User Fee Amendments Read More »
By Adele M. Kaplan Gilpin, J.D., Ph.D. and John G. Moore, J.D., Ph.D., Hunton & Williams LLP
Published September 6, 2012
Once it’s alleged, what happens next? Read More »
Published February 27, 2012
Issued by the U.S. FDA when communicating a decision to a drug company that an NDA or ANDA to market a new or generic drug will not be approved in its present form. Before August 2008, the FDA used Approvable and Not Approvable letters in these cases… Read More »
By Gary C. Messplay, J.D.
Published May 10, 2010
New proposed rule from FDA to ensure data validity Read More »
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