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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Advisory Opinion 24-02 on the Scope of States’ Authority to Exclude Providers from Participation under a Medicaid State Plan December 11, 2024  Office of the General Counsel (OGC) Final
Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and CHIP  Centers for Medicare & Medicaid Services (CMS) Final
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Accelerated Approval – Expedited Program for Serious Conditions  Food and Drug Administration (FDA) Proposed
Protecting Medicaid Beneficiaries Against Impermissible Fraud and Abuse Sanctions (SMD 24-005) [RESCINDED ON MAY 1, 2025]  Centers for Medicare & Medicaid Services (CMS) Final
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability  Food and Drug Administration (FDA) Final
Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects  Food and Drug Administration (FDA) Proposed
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