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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 #281 Infectious Otitis Externa Drugs for Topical Use in Dogs  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 #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs  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
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed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
CVM GFI #290 (VICH GL61) – Pharmaceutical Development  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
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Data Integrity for In Vivo Bioavailability and Bioequivalence Studies  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11384 documents.