In the shadow of final negotiations over PDUFA reauthorization, the agency is inviting patients, their representatives, industry and academics to discuss how best to use patient input in decisions on regulated drugs, devices and biologics.
FDA’s latest move to integrate patient input into regulatory decision-making on drugs, devices and biologics is a May 18 meeting to be held at the agency’s White Oak, Silver Spring, Md. headquarters.
The agency says it will welcome patients, caregivers, independent patient advocates, patient advocate groups, academics, industry representatives and health professional groups to the meeting. FDA will use the occasion to...
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
