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© 2023 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
February 03, 2023
Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.
January 31, 2023
Face-to-face meetings will now include in-person and virtual components.
January 30, 2023
Agency panel backs the use of a common bivalent shot for all patients.
January 09, 2023
House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.
December 22, 2022
The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.
December 02, 2022
Looking back on major FDA moves in 2022.
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.