In letters to congressional leaders, generic drug trade group outlines six proposals that it says would save the government billions of dollars and lessen the impact of sequestration cuts.
The Generic Pharmaceutical Association has outlined six ideas for how Congress can reduce government spending through increased generic drug utilization but is making the strongest push for proposals related to the Medicare low-income subsidy population and misuse of restrictive Risk Evaluation and Mitigation Strategies.
Many, if not all, of the health care savings proposals have been floated in one form or another by GPhA and other stakeholders in recent years, including during the run...
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.
