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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
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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Considerations for Rescinding Breakthrough Therapy Designation  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
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products  Food and Drug Administration (FDA) Proposed
Considerations in Demonstrating Interchangeability With a Reference Product: Update  Food and Drug Administration (FDA) Proposed
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.