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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
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality  Food and Drug Administration (FDA) Proposed
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
FDA Records Access Authority for Cosmetic Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
E22 General Considerations for Patient Preference Studies  Food and Drug Administration (FDA) Proposed
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals  Food and Drug Administration (FDA) Final
2027 Updates to the Child and Adult Core Health Care Quality Measurement Sets and Mandatory Reporting  Centers for Medicare & Medicaid Services (CMS) Final
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Exercise of Enforcement Discretion until Calendar Year 2029 for Medicaid Interested Parties Advisory Group  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 11397 documents.