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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 #159 (VICH GL36) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI  Food and Drug Administration (FDA) Final
Good ANDA Submission Practices Guidance for Industry  Food and Drug Administration (FDA) Final
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders  Food and Drug Administration (FDA) Final
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Final
Federal Independent Dispute Resolution (IDR) Process Guidance for Disputing Parties  Centers for Medicare & Medicaid Services (CMS) Final
e-NMSN Software Interface Specification   Administration for Children and Families (ACF) Final
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Proposed
Federal Independent Dispute Resolution (IDR) Process Guidance for Certified IDR Entities  Centers for Medicare & Medicaid Services (CMS) Final
Federal Independent Dispute Resolution (IDR) Process Guidance for Certified IDR Entities  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4742 documents.