60 updates found
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…
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special contr…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amen…
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the …
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the …
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Ma…
The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool into class II (special controls). The special controls…
The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device into class II (special controls). The special controls…
The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls). …
The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression into class II (special controls)…
The Food and Drug Administration (FDA or we) is issuing an order to repeal the color additive regulation that allows for the use of Orange B for coloring the c…
The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus R…
The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Control…
