Regulatory Beat

Nov 21, 2017
By BioPharm International Editors
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
Nov 01, 2017
BioPharm International
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Nov 01, 2017
BioPharm International
Reliable, high-quality products require innovative analytics and production.
Oct 01, 2017
BioPharm International
Industry and FDA face new fee structures and new challenges in implementing fee initiatives.
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.
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