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By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
By Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations Read More »
By Gil Roth
Published March 25, 2013
PAI waived, Cook Pharmica to help reduce drug shortage Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published November 16, 2011
Also passes sixth product PAI Read More »
Published August 19, 2011
Joint inspection focused on increasing international regulatory collaboration Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
By Dilip M. Parikh
Published August 22, 2005
Outsourcing offers companies a new option in this regulatory process. Read More »


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