On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs.

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

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

On December 29, 2020, the U.S Food and Drug Administration (FDA) issued a notice announcing the first ever fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA).

FDA’s user fee programs are pay-for-performance programs because the agency’s authorizing statute the Federal Food, Drug, and Cosmetic Act FD&C Act specifies certain ...

The basic user-fee program for drugs and biologics hashed out by manufacturers and FDA officials over the previous 18 months remained intact during the legislative process. Generic-drug makers agreed ...

On Wednesday, June 15, the Senate Committee on Health, Education, Labor and Pensions advanced its version of the must-pass Food and Drug Administration (FDA) user fee reauthorization bill.

Initially passed in 1992 and 2002, respectively, PDUFA (Prescription Drug User Fee Amendments) and MDUFA (Medical Device User Fee Amendments) require reauthorization every five years. Hearings for ...

FDA's User-Fee Habit. April 3, 2007 More than ... pharmaceutical companies have poured $2 billion into a program that helps finance the U.S. Food and Drug Administration , ...

FDA user fees for other sectors are often directly negotiated with industry trade groups. ... FDA user fees: examining changes in medical product development and economic benefits [Internet].

WASHINGTON -- The Food and Drug Administration's deal with the pharmaceutical industry about user fees that companies pay the agency to review their products will likely prove a starting point for ...

A deal aimed at allowing the Food and Drug Administration to collect $400 million-plus annually in additional user fees could speed up pharmaceutical and device approvals, according to industry ...