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 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.

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 … ...

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 ...