All statin labels now warn that “increases in HbA1C and fasting serum glucose levels have been reported” with the cholesterol-lowering drugs. Labels also reflect a relaxation of hepatic monitoring requirements, which could remove one hurdle to Pfizer’s pursuit of an OTC switch for Lipitor.
All cholesterol-lowering statin drugs will carry a uniform warning about the potential for increased blood sugar levels, pursuant to a class-wide labeling change announced by FDA Feb. 28.
The Warnings and Precautions section of all statin labels now includes a subsection on Endocrine Function with the following statement: “Increases in HbA1c and fasting serum glucose levels have been...
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.
