According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

The post Targeting FDA user fees would leave agency gutted, experts say appeared first on Roll Call. ... Kennedy wrote that he wanted to reform the prescription drug user fee program at the FDA.

The Prescription Drug User Fee Act of 1992 (PDUFA) added sections 735 and 736 to the Federal Food, Drug, and Cosmetic Act (FDCA), and authorized FDA to collect user fees from persons that submit ...

FDA staff cuts have claimed negotiators integral to upcoming reauthorization talks on the FDA's funding-dependent user fee program, Reuters reports.

User fee program key to funding for FDA's drug reviews; Talks between FDA, pharma industry for program renewal in 2027 due to begin; FDA job cuts include 15 staff preparing for those talks ...

Employees include at least one drug user fee negotiator At least nine other staff supporting the program are asked back FDA asks employees to return for second time this year May 2 (Reuters) - The ...

We find that a new comprehensive FDA user fee program for food may benefit industry and generate targeted new resources to strengthen the agency’s oversight. Create a new account.

Last year, three-fourths of the FDA’s drug division budget, more than $1 billion, was from its user fee program, in which pharmaceutical companies and devicemakers pay fees to the agency as part ...

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recenlty announced the fee rates and payment procedures for fiscal year (FY) 2025 under the Animal Drug and Animal Generic Drug User … ...

The new Prescription Drug User Fee Act date is March 18, 2025. The FDA has extended its Prescription Drug User Fee Act date for the biologics license application for NT-501, a treatment for ...

Under the law, the FDA is required to set a date by which it must make a determination on whether to approve products. In the following years, Congress authorized additional user fee programs for ...

LONDON/WASHINGTON (Reuters) -The U.S. Food and Drug Administration's mass layoffs included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that ...