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Warning Letters Galore
By Martin Lush, NSF-DBA
Published May 4, 2012
Causes and prevention: What can we learn from the mistakes of others? Read More »
Drug Interaction Studies
By Chris Bode, Absorption Systems
Published May 4, 2012
A new FDA Draft Guidance reflects a fast-changing field Read More »
By Gil Roth, Contract Pharma
Published May 4, 2012
FDA’s draft guidance leads to new opportunities Read More »
By Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
Published May 4, 2012
FDA releases guidance on direct-to-consumer TV advertisements Read More »
By Heather Banuelos
Published April 4, 2012
FDA provides draft guidance on biosimilar product development Read More »
Packaging Trends and Anti-counterfeiting Initiatives
By Kristin Brooks
Published April 4, 2012
Contract packagers and suppliers see opportunities Read More »
Published March 22, 2012
New lab suite offers analytical testing, development support and regulatory services Read More »
By Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
Published March 7, 2012
New guidance seeks to clear up manufacturer communications Read More »
Clinical Trial Outsourcing Report
By Steven Aldrich, Kalorama Information
Published March 7, 2012
Where are the opportunities in the $36.6 billion market for outsourcing clinical trials? Read More »
Rethink Training
By Ellen Leinfuss, Kaplan EduNeering
Published March 7, 2012
Four reasons your FDA compliance training isn’t preventing violations — and how you can change that Read More »
Packaging Serialization Update
By Stephen Barlas, Contributing Writer
Published March 7, 2012
FDA reviews obsolete 2004 barcode rule Read More »
By Tim Clark
Published February 29, 2012
An initial take on the Agency's proposal for biosimilars Read More »
By Gil Roth
Published February 28, 2012
Value strategy consultancy deepens pricing and market access capabilities Read More »
By Gil Roth
Published February 22, 2012
New facility increases bioreactor capacity from 1000 to 8000L Read More »
Harmonized Tariff Schedule Classification
By Robert E. Schwartz
Published January 23, 2012
Importation of Organic Chemicals into the U.S. Read More »
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