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Health and Human Services Department, Food and Drug Administration · 2026-09-25
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.
Health and Human Services Department, Food and Drug Administration · 2026-09-25
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Health and Human Services Department, Food and Drug Administration · 2026-09-25
The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
Health and Human Services Department, Food and Drug Administration · 2026-09-25
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color additive regulations to provide for the safe use of calcium sulfate in various foods at levels consistent with good manufacturing practice.
HHS-FDA · Opens 11/24/2023
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HHS-FDA · Opens 06/25/2025 · Closes 04/01/2027
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HHS-FDA · Opens 08/14/2024
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HHS-FDA · Opens 08/14/2024
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