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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents: Draft…  Food and Drug Administration (FDA) Proposed
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for the Durable Medical Equipment Industry  Office of Inspector General (OIG) Proposed
This Guidance Portal contains 46923 documents.

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