153 updates found
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for importers approved to participate in the Voluntary Qua…
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), …
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and…
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that…
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug …
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. T…
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certifi…
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 fee rates for certain domestic and foreign facility reinspections, failure…
The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027…
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for prescription drug user fees for fiscal year (FY) 2027. The Federal Food, Drug…
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special co…
The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve effic…
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances pro…
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), …
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), …
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligi…
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The g…
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the …
The Food and Drug Administration (FDA) is amending a notice entitled "Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026" that appeared in the Fe…
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special c…
