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November 10, 2022
Following closely contested election, approval of FDA bills most likely tabled until new year.
October 26, 2022
Potential drug removal spotlights latest debate over the expedited pathway.
October 12, 2022
CBER maps modernization plan to handle surge in research and applications.
October 06, 2022
The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.
September 29, 2022
Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.
September 23, 2022
Seek pared-down measure in funding bill to avert shutdown.
September 20, 2022
Agency officials express associated concerns around clinical trial data reliability and quality.
September 16, 2022
Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.
September 12, 2022
In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.
August 15, 2022
Pharma loses battle to block price negotiations, but implementation faces many challenges.