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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 #287 - Raw Data for Safety and Effectiveness Studies  Food and Drug Administration (FDA) Final
Medicare Advantage Prescription Drug System June 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
Deadlines for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
FAQs About the 10% Enrollment Requirement  Administration for Children and Families (ACF) Final
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Data Reporting Compliance for the Transformed-Medicaid Statistical Information System (T-MSIS)  Centers for Medicare & Medicaid Services (CMS) Final
Updated 2025 SSI and Spousal Impoverishment Standards  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4741 documents.