OR WAIT null SECS
February 01, 2022
The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
January 01, 2022
To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.
December 01, 2021
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
November 01, 2021
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
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.