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By Gil Roth
Published December 9, 2013
Helsinn, Eisai file for netupitant, palonosetron combo Read More »
By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
By Gil Roth
Published July 27, 2011
Synthesis sites in France, Bahamas pass muster Read More »
By Heather D. Bau00f1uelos
Published July 13, 2011
A busy year for the agency Read More »
Published May 11, 2011
New trials are necessary for patient safety Read More »
By Stephen Barlas
Published February 15, 2011
Confusion, anxiety reign as Agency talks tagging Read More »
Trends in 505(b)(2) Approvals
By Loren Gelber
Published March 3, 2010
The who, what, why, when and how of this hybrid application process Read More »
By Gary C. Messplay, J.D.
Published April 30, 2008
Proposed rule to codify long-standing policy stirs debate Read More »
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