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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 #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
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect  Food and Drug Administration (FDA) Proposed
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.