Jill Wechsler, ACT's Washington Correspondent

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

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

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

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

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

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

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.

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

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

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

Plan to keep new methods adopted during COVID in place.

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

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.

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

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

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

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

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

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.

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

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

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

Political issues delay Senate confirmation of Califf.

New package to clarify responsibilities for federal health agencies.

Uncertainty over experimental medicines calls for review of AA process.

International collaboration needed to address distribution hurdles.

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.