OR WAIT null SECS
© 2022 MJH Life Sciences and Pharmaceutical Executive. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Executive. All rights reserved.
Jill Wechsler is Pharm Exec's Washington Corespondent
Plan to keep new methods adopted during COVID in place.
Access to mifepristone, approved by the agency in 2000, also under microscope.
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.