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Critical Design Strategies for Extractables and Leachables Control
By Thomas Feinberg, Catalent Pharma Solutions
Published April 3, 2013
Methods for avoiding contamination Read More »
By Gil Roth
Published March 25, 2013
PAI waived, Cook Pharmica to help reduce drug shortage Read More »
Published February 20, 2013
Expands manufacturing and support facilities in Craigavon Read More »
By Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
Published January 22, 2013
FDA revises draft guidance document to address industry comments Read More »
Published November 14, 2012
2010 warning letter sited nine issues Read More »
Published October 8, 2012
Reviewed systems, processes and procedures, with no Form 483 observations Read More »
Published September 12, 2012
Four newly approved sites expand presence in U.S. market Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published August 12, 2011
To manufacture a solid dose product for a client Read More »
By Gary C. Messplay and Colleen Heisey
Published January 22, 2010
A busy year for the agency Read More »
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