Jill Wechsler, Pharm Exec’s Washington Correspondent

Recent lawsuits are challenging the constitutionality of provisions in the Inflation Reduction Act.

Pandemic preparedness and curbing PBMs among the pending legislation that will have to wait until after summer recess.

The agency proposes significant revisions to oversight programs for drugs and medical products.

The confirmatory study—which tracked 18 months of data—helped clear the way for new Alzheimer’s drug.

Could feel the impact from potential new provisions to legislation reauthorizing US international health programs.

Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.

New program seeks to reduce misuse and adverse reactions by simplifying prescription labels.

Agency hopes to update and improve its advisory committee composition and operations—to help FDA scientists “get the best advice possible.”

Amid drug pricing blame game, Congress advancing a range of reform efforts to manage and curb pharmacy benefit manager practices.

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.

Legal experts: Ruling on abortion pill could spur challenges involving other authorized medical products.

Agency hopes to attract more seasoned expertise in manufacturing; also looking to add field inspectors.

Impact areas that will be closely watched during phase-out include drug testing and authorization, telehealth, and patient access.

Amid continued tussling over drug costs, a new working group will review the government’s authority to revoke licenses for medical products.

Manufacturer to withdraw preterm birth drug, amid latest FDA push.

New candidates are targeting cancer, infectious diseases, and RSV.

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Addresses a host of issues and policy priorities impacting pharma.

Probe targets agency’s role in advising on drug testing and submissions.

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.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Current virus “triple whammy” taxes supply levels, while raising concerns over FDA’s limited power to track drug demand spikes.