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

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 ...

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 ...

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

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 ...

The report claims the 15 people who were fired included the head negotiator and deputy negotiator for one of the user fee agreements, which could set back the reauthorization of agreements.

The user fee for VQIP in fiscal year 2025 covers the period from October 1, 2024, to September 30, 2025. Importers approved for VQIP must pay the fee by October 1, 2024, to begin receiving benefits.

The mass layoffs at the FDA included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the agency drug review system, Reuters reports ...

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 … ...

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.

U.S. health regulators said on Friday they have submitted to Congress new recommendations for how manufacturers will help fund their review of new branded drugs, conventional generic medicines and ...

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 ...