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By Gil Roth
Published January 9, 2014
Hires Quintiles to run PK study Read More »
By Gil Roth
Published December 4, 2013
Will enroll patients for IIb/III AF study Read More »
Published November 5, 2013
Resolves all issues at Burlington facility Read More »
By Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
By Gil Roth
Published October 30, 2013
MannKind tries again with inhaled insulin Read More »
Critical Design Strategies for Extractables and Leachables Control
By Thomas Feinberg, Catalent Pharma Solutions
Published April 3, 2013
Methods for avoiding contamination Read More »
Published March 28, 2013
RVW provides cold storage and visual inspection Read More »
Published May 25, 2010
The FDA has finalized the terms of the consent decree regarding Genzyme’s Allston manufacturing plant, subject to approval by the U.S. District Court for the District of Massachusetts. Read More »
Published August 19, 2009
Catalent's softgel facility in Buenos Aires successfully completed its first FDA cGMP audit and PAI Read More »
Published September 14, 2007
Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiat… Read More »
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