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

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

This legal and policy analysis evaluates the FDA’s food-related authorities that would be amenable to a new user fee program.

As FDA kicked off the drug user fee reauthorization process, Commissioner Marty Makary said he’d like to see lower fees paid ...

The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for ...

Medical product user fees generate some $2 billion in agency revenues, about 40% of FDA’s non-tobacco budget. While Congressional leaders on both sides of the aisle support this program to bolster key ...

Moving forward The “skinny” user fee reauthorization dropped multiple high-profile proposals for revising how FDA regulates in vitro diagnostics, dietary supplements, and cosmetics, as well as the ...

FDA officials posed four questions ahead of the public meeting. The agency wants to know what people think of the overall performance of Medical Device User Fee Amendments V so far.

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...

6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time A failure to swiftly reauthorize user fees could slow the FDA’s ability to review medical devices and ...

Predecessor legislation authorizing user fees at FDA from the 1990s pointed to a “different mission—to protect the public and promote public health by encouraging innovation,” she says.

Pharmalittle: We’re reading about FDA layoffs hurting user fee programs, pharma tariffs, and more The FDA will remove industry representatives from advisory committees Alex Hogan/STAT By Ed ...