Regulatory Beat

Sep 01, 2017
BioPharm International
FDA works with industry on strategies for assuring high-quality regenerative medicines.
Aug 01, 2017
BioPharm International
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Jul 01, 2017
BioPharm International
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jun 01, 2017
BioPharm International
Approval of breakthrough therapies requires expedited quality assessment.
May 01, 2017
BioPharm International
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Apr 01, 2017
BioPharm International
Industry fears limited benefits as FDA readies voluntary data tracking program.
Mar 01, 2017
Manufacturers face uncertainty over imports, regulatory policies, and field inspections.
Feb 01, 2017
BioPharm International
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
Jan 01, 2017
BioPharm International
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
Dec 01, 2016
BioPharm International
Republican control of Washington promises overhaul of healthcare and medical product regulation.
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