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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
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Blood Establishment Computer System Validation in the User's Facility: Guidance for Industry  Food and Drug Administration (FDA) Final
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings: Guidance for Industry  Food and Drug Administration (FDA) Final
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests: Guidance for Industry  Food and Drug Administration (FDA) Final
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.