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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 Sort ascending
S7A Safety Pharmacology Studies for Human Pharmaceuticals  Food and Drug Administration (FDA) Final
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for Industry  Food and Drug Administration (FDA) Final
CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission  Food and Drug Administration (FDA) Final
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials  Food and Drug Administration (FDA) Final
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Foster Family Home Licensing Principles for Compliance with Titles IV-B and IV-E Requirements: Guidance for States  Administration for Children and Families (ACF) Final
Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry  Food and Drug Administration (FDA) Final
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff  Food and Drug Administration (FDA) Final
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)  Food and Drug Administration (FDA) Final
E10 Choice of Control Group and Related Issues in Clinical Trials  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4024 documents.