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Published October 7, 2014
Will continue to pursue FDA approval of daclatasvir Read More »
The Audit Trail Advantage
By Carol Brandt , GMP Compliance Consulting, NNE Pharmaplan
Published September 8, 2014
Why one of FDA’s most misunderstood rules can help ensure data integrity and compliance, and help in root cause analysis 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 »
Generic Manufacturing: GDUFA & CMOs
By Gil Y. Roth, Contract Pharma
Published March 6, 2013
Generic facility fees cause sticker shock Read More »
By S. Harachand, Contributing Editor
Published October 11, 2012
Have CMOs gained the edge over captives? 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 »
By E. Morrey Atkinson. Ph.D.
Published October 11, 2011
Both Sides of the Table – A discussion of CMO/client perspectives Read More »
By Marian Robinson
Published June 9, 2011
A new FDA guidance is set to prompt manufacturers into action Read More »
By Colleen Heisey, J.D.
Published April 5, 2011
FDA drafts guidance on best practices Read More »
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