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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 #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines  Food and Drug Administration (FDA) Proposed
CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines  Food and Drug Administration (FDA) Proposed
Data Integrity for In Vivo Bioavailability and Bioequivalence Studies  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence  Food and Drug Administration (FDA) Proposed
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect  Food and Drug Administration (FDA) Proposed
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.