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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 November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
By Gil Roth
Published October 9, 2013
End-of-Phase II meeting goes smoothly 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 February 22, 2013
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater acce… Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
Published April 25, 2012
FDA to accept some studies, require reanalysis for others Read More »
Published January 24, 2012
U.S. patients will return to full Fabrazyme dosing in March Read More »
Published August 19, 2011
Joint inspection focused on increasing international regulatory collaboration Read More »


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