View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

Several legislative initiatives on table that would extend agency’s reach

FDA Seeks Expanded Authorities, Along With More Funds

IP claims under microscope amid arguments over R&D policy and investment.

Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

FDA, Congress Re-Examine Accelerated Approval Program

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

FDA Maps Strategies to Advance Pharmaceutical Quality

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Federal Budget Bill Boosts FDA Funding, Supports New Research Institute

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Ukraine Invasion Challenges Biopharma Research and Operations

Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.

FDA Nixes Approvals Based Only on Foreign Data

Pressurized political, COVID climates greet his return to top spot.

A Rocky Road Ahead for New FDA Chief Califf 

Agency restarts more routine site visits amid slowdown of new COVID infections.

FDA Faces Huge Task Catching Up On Inspections

Political issues delay Senate confirmation of Califf.