Jill Wechsler

The agency will be reorganizing field force and compliance functions.

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Pandemic, PBM, and other policies on hold during the summer recess.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Problems continue despite actions by regulators to better prevent and address drug shortages.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

An increase in applications for gene therapies is putting stress on FDA’s resources.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.