Jill Wechsler, Pharm Exec’s Washington Correspondent

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

2023 is poised to deliver a new set of challenges.

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

Regulation revision now allows pharmacies to dispense mifepristone directly to individuals with a prescription.