View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

Seek pared-down measure in funding bill to avert shutdown.

Congress Slated to Reauthorize User Fees, Without FDA ‘Improvements’ 

Agency officials express associated concerns around clinical trial data reliability and quality.

Clinical Trial Modernization Raises FDA Compliance Issues

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

Advanced Biopharma Manufacturing Key to White House Cancer Moonshot

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

FDA in Limbo as User Fee Renewal Stuck on Capitol Hill

Pharma loses battle to block price negotiations, but implementation faces many challenges.

New Legislation Overhauls Medicare Drug Pricing and Benefits

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.