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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Final
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order: Guidance for Tobacco Retailers  Food and Drug Administration (FDA) Final
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2): Guidance to Industry and FDA Staff  Food and Drug Administration (FDA) Final
Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
Q3D(R2) – Guideline for Elemental Impurities: International Council for Harmonisation; Draft Guidance for Industry  Food and Drug Administration (FDA) Final
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals : International Council for Harmonisation; Draft Guidance for Industry  Food and Drug Administration (FDA) Final
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products  Food and Drug Administration (FDA) Final
Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen: Memorandum to All Registered Blood Establishments  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4033 documents.