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By Gil Roth
Published January 8, 2014
Natpara action date October 2014 for hypoparathyroidism indication Read More »
By Gil Roth
Published December 2, 2013
AcelRx pain management system to be reviewed Read More »
By Gil Roth
Published March 25, 2013
PAI waived, Cook Pharmica to help reduce drug shortage Read More »
Published May 18, 2012
Provides input at public hearing Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March Read More »
By Gil Roth
Published January 17, 2012
Elder leaves agency after more than two decades 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 »
FDA Expectations for Parenteral Supplier Controls
By John Avellanet
Published November 10, 2010
Does a device guidance hold the key? Read More »


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