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 ...

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

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].

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

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 ...

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

Congress has reauthorized PDUFA multiple times, and user fees now comprise over half of FDA’s drug review budget. Eliminating user fees would require an act of Congress, and further require ...

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.