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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
Classification Categories for Certain Supplements Under BsUFA III  Food and Drug Administration (FDA) Final
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies: Considerations for Study Design  Food and Drug Administration (FDA) Proposed
Clinical Pharmacology Considerations for Peptide Drug Products  Food and Drug Administration (FDA) Proposed
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics  Food and Drug Administration (FDA) Proposed
Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention  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
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers  Food and Drug Administration (FDA) Final
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.