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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
April 2025 Quarterly Update to Healthcare Common Procedure Coding System (HCPCS) Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement  Centers for Medicare & Medicaid Services (CMS) Final
Annual Request for Part D Payment Reconciliation Contact Information 2025 G  Centers for Medicare & Medicaid Services (CMS) Final
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process  Food and Drug Administration (FDA) Final
CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease  Food and Drug Administration (FDA) Proposed
CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)  Food and Drug Administration (FDA) Final
CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
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