View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Kudos and Hurdles in Tackling Rare Diseases

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Analysis: IRBs Need More Monitoring 

Probe targets agency’s role in advising on drug testing and submissions.

FDA Interactions With Industry Under the Microscope

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.

Clinical Trial Diversity Continues to Face Challenges

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

FDA Food Center Reorganization Puts Field Inspections in Limbo

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

FDA Resumes In-Person Meetings with Industry…Sort Of

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

FDA Seeks to Simplify COVID Vaccination Program

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

Congressional Probe of Alzheimer’s Drug Hits FDA Interactions with Industry

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