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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 #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds  Food and Drug Administration (FDA) Final
CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV  Food and Drug Administration (FDA) Final
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices  Food and Drug Administration (FDA) Final
CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter  Food and Drug Administration (FDA) Final
CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #271 Reporting and Mitigating Animal Drug Shortages  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.