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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
Small Entity Compliance Guide: What You Need to Know About Establishment and Maintenance of Records  Food and Drug Administration (FDA) Final
Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry  Food and Drug Administration (FDA) Final
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products  Food and Drug Administration (FDA) Final
Special Protocol Assessment Guidance for Industry  Food and Drug Administration (FDA) Final
Specification of the Unique Facility Identifier (UFI) System for Drug Establishment  Food and Drug Administration (FDA) Final
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments  Food and Drug Administration (FDA) Final
Statistical Approaches to Establishing Bioequivalence  Food and Drug Administration (FDA) Final
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Street Drug Alternatives  Food and Drug Administration (FDA) Final
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.