View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

FDA Eyes New Strategies to Spur Gene Therapy Development

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.

Court Ruling Leaves FDA Authority in Limbo

Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.

FDA Regulatory Authority Under Attack

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.

FDA, Industry Prepare for End to COVID Health Emergency

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.