View from Washington

Jill Wechsler is ACT's Washington Correspondent

Articles

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ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.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