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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 15, 2021
After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.
October 01, 2021
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
September 01, 2021
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
August 20, 2021
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
August 01, 2021
Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
July 01, 2021
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
June 01, 2021
Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
May 01, 2021
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
March 01, 2021
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
February 01, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.