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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 descending Issue Date
Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry  Food and Drug Administration (FDA) Proposed
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Proposed
Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice for Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Male Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Product Labeling for Laparoscopic Power Morcellators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 47297 documents.

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