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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.
March 03, 2023
The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.
February 23, 2023
Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.
February 15, 2023
Probe targets agency’s role in advising on drug testing and submissions.
February 13, 2023
With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.
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.