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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
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration…  Food and Drug Administration (FDA) Proposed
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance…  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making  Food and Drug Administration (FDA) Proposed
Over-the-Counter Monograph Order Requests: Format and Content  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry  Food and Drug Administration (FDA) Proposed
Mpox: Development of Drugs and Biological Products; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Migraine: Developing Drugs for Preventive Treatment  Food and Drug Administration (FDA) Proposed
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.