Columns | View from Washington

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ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.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

New therapies were approved at a steady pace in 2021.

Pfizer’s Paxlovid has gained emergency use authorization at a time when the U.S. is being devastated by the spreading Omicron variant.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient, mifepristone.

The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on Dec. 14, setting the stage for full Senate approval early next year.

President Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Lessons learned from COVID-19 vaccine development.

FDA scientists are working to advance gene and cellular therapies, with new guidances for manufacturers on appropriate testing of treatments to minimize risks to patients and fill data gaps.