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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
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products  Food and Drug Administration (FDA) Proposed
Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for Industry  Food and Drug Administration (FDA) Final
Frequently Asked Questions (FAQs) Improving Maternal Health and Extending Postpartum Coverage in Medicaid and the Children’s Health Insurance Program (CHIP) (SHO #21-007)  Centers for Medicare & Medicaid Services (CMS) Final
LIHWAP AT-2024-02 Annual Report Submission FY2024  Administration for Children and Families (ACF) Final
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food  Food and Drug Administration (FDA) Proposed
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products  Food and Drug Administration (FDA) Final
CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine  Food and Drug Administration (FDA) Final
CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data  Food and Drug Administration (FDA) Final
Legal Orientation Program for Custodians Overview: English  Administration for Children and Families (ACF) Final
This Guidance Portal contains 3999 documents.