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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
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  Food and Drug Administration (FDA) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations in Demonstrating Interchangeability With a Reference Product: Update  Food and Drug Administration (FDA) Proposed
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products  Food and Drug Administration (FDA) Proposed
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  Food and Drug Administration (FDA) Proposed
CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines  Food and Drug Administration (FDA) Proposed
CPG Sec 100.101 Crotalaria spp. Seeds in Grains  Food and Drug Administration (FDA) Proposed
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.