Jill Wechsler is ACT's Washington Correspondent
FDA in Limbo as User Fee Renewal Stuck on Capitol Hill
In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.
New Legislation Overhauls Medicare Drug Pricing and Benefits
Pharma loses battle to block price negotiations, but implementation faces many challenges.
Top Priority for Califf is Combating Health Misinformation
Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
FDA Confirms Ongoing Reliance on Remote Inspection Methods
Citing strong reporting results, hybrid model to continue supplementing on-site inspections.
FDA Continues to Grapple with Accelerated Approval Issues
With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.
Gamesmanship Escalates Over FDA User Fee Legislation
With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.
Regulators Seek More Drug Effects Research Related to Pregnancy, Lactation
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.
A Defining Period for Future of FDA
Agency leaders seek to build public trust in science and gain support for regulation.
FDA User Fee Legislation Advances in Senate
Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.
New Guidelines Aim to Advance Pediatric Drug Development
ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.
FDA to Continue Inspection Efficiencies After Pandemic
Plan to keep new methods adopted during COVID in place.
Congress Presses FDA on Key Policies and Operations
Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.
Clinical Trial Diversity Advances in Regulatory Agenda
Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.
FDA, Industry Prepare for Post-EUA World
Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.
FDA Revives Initiative to Identify and Reward Quality Drug Operations
Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.
Legislation Targets High Cost of Clinical Trials
Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.
FDA Seeks Expanded Authorities, Along With More Funds
Several legislative initiatives on table that would extend agency’s reach
Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On
IP claims under microscope amid arguments over R&D policy and investment.
FDA, Congress Re-Examine Accelerated Approval Program
Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.
FDA Maps Strategies to Advance Pharmaceutical Quality
Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.
Federal Budget Bill Boosts FDA Funding, Supports New Research Institute
The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.
Ukraine Invasion Challenges Biopharma Research and Operations
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.
FDA Nixes Approvals Based Only on Foreign Data
Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.
A Rocky Road Ahead for New FDA Chief Califf
Pressurized political, COVID climates greet his return to top spot.
FDA Faces Huge Task Catching Up On Inspections
Agency restarts more routine site visits amid slowdown of new COVID infections.
FDA Caught in Crossfire
Political issues delay Senate confirmation of Califf.
Pandemic Preparedness Legislation Bolsters FDA Oversight
New package to clarify responsibilities for federal health agencies.
Concerns Mount Over Limited Evidence for Accelerated Approvals
Uncertainty over experimental medicines calls for review of AA process.
Global Vaccine Access Challenges FDA, Industry
International collaboration needed to address distribution hurdles.
Medicare Limits Aduhelm Coverage to Patients in Clinical Trials
In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.