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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
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
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules  Food and Drug Administration (FDA) Final
Slit Lamp Guidance - Guidance for Industry  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.