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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
Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Safety Testing of Drug Metabolites  Food and Drug Administration (FDA) Final
Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception  Food and Drug Administration (FDA) Final
Sample WHO Certificate for Quality of a Pharmaceutical Product  Food and Drug Administration (FDA) Final
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product  Food and Drug Administration (FDA) Final
Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry  Food and Drug Administration (FDA) Final
Self-Selection Studies for Nonprescription Drug Products  Food and Drug Administration (FDA) Final
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry  Food and Drug Administration (FDA) Final
Shelf Life of Medical Devices  Food and Drug Administration (FDA) Final
Single Dose Acute Toxicity Testing for Pharmaceuticals  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.