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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
Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals  Food and Drug Administration (FDA) Proposed
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles  Food and Drug Administration (FDA) Proposed
CVM GFI #290 (VICH GL61) – Pharmaceutical Development  Food and Drug Administration (FDA) Proposed
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use  Food and Drug Administration (FDA) Proposed
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products  Food and Drug Administration (FDA) Proposed
CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs  Food and Drug Administration (FDA) Proposed
CVM GFI #239 Human Food By-Products For Use As Animal Food  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.