View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Top Priority for Califf is Combating Health Misinformation 

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

FDA Confirms Ongoing Reliance on Remote Inspection Methods 

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

FDA Continues to Grapple with Accelerated Approval Issues

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Gamesmanship Escalates Over FDA User Fee Legislation

Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.

Regulators Seek More Drug Effects Research Related to Pregnancy, Lactation

Agency leaders seek to build public trust in science and gain support for regulation.

A Defining Period for Future of FDA

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access. 

FDA User Fee Legislation Advances in Senate

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

New Guidelines Aim to Advance Pediatric Drug Development

Plan to keep new methods adopted during COVID in place.

FDA to Continue Inspection Efficiencies After Pandemic

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.