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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 #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
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process  Food and Drug Administration (FDA) Final
CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food  Food and Drug Administration (FDA) Final
CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients  Food and Drug Administration (FDA) Final
CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals  Food and Drug Administration (FDA) Final
CVM GFI #35 Bioequivalence Guidance  Food and Drug Administration (FDA) Final
CVM GFI #5 Drug Stability Guidelines  Food and Drug Administration (FDA) Final
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials  Food and Drug Administration (FDA) Final
CVM GFI #57 Preparation and Submission of Veterinary Master Files  Food and Drug Administration (FDA) Final
CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.