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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
Hypnotic Drugs--Clinical Evaluation  Food and Drug Administration (FDA) Final
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees  Food and Drug Administration (FDA) Final
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry  Food and Drug Administration (FDA) Final
Mouse Embryo Assay for Assisted Reproduction Technology Devices  Food and Drug Administration (FDA) Final
E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)  Food and Drug Administration (FDA) Final
Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs  Food and Drug Administration (FDA) Final
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas  Food and Drug Administration (FDA) Final
Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act  Food and Drug Administration (FDA) Final
Laser Energy Source (Laser Notice 2)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.