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 ...

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 ...

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].

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

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

As one FDA initiative works to sustain the momentum of rare disease research, other events threaten to slow progress.

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.

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

Pharmalittle: We’re reading about FDA layoffs hurting user fee programs, pharma tariffs, and more The FDA will remove industry representatives from advisory committees Manage alerts for this article ...

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.

The Food and Drug Administration (FDA) has accepted the New Drug Application for doravirine/islatravir (DOR/ISL) for adults with virologically-suppressed HIV-1 infection.