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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 »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published February 20, 2013
Expands manufacturing and support facilities in Craigavon Read More »
Published February 6, 2013
U.S. commercial packaging operations underway Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
By Gil Roth
Published July 31, 2012
No 483s at Clinical Pharmacology Unit Read More »
FDA Expectations for Parenteral Supplier Controls
By John Avellanet
Published November 10, 2010
Does a device guidance hold the key? 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 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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