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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
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect  Food and Drug Administration (FDA) Proposed
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Final
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Levels for Lead in Juice  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.