View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation. 


Following closely contested election, approval of FDA bills most likely tabled until new year.

Potential drug removal spotlights latest debate over the expedited pathway.

CBER maps modernization plan to handle surge in research and applications. 

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.