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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 #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
CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover  Food and Drug Administration (FDA) Final
CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs  Food and Drug Administration (FDA) Final
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications  Food and Drug Administration (FDA) Final
CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.