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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
Billing Instructions Related to Expedited Determinations Based on Medicare Change of Status Notifications (MCSNs)  Centers for Medicare & Medicaid Services (CMS) Final
Reminders Related to the Medicare Prescription Payment Plan G  Centers for Medicare & Medicaid Services (CMS) Final
Medicare Advantage Prescription Drug System INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
E6(R3) Good Clinical Practice: Annex 2  Food and Drug Administration (FDA) Proposed
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Proposed
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices  Food and Drug Administration (FDA) Proposed
E11A Pediatric Extrapolation  Food and Drug Administration (FDA) Final
Advanced Manufacturing Technologies Designation Program  Food and Drug Administration (FDA) Final
Medicare Benefit Policy Manual, Chapter 15 Update for Dental Services   Centers for Medicare & Medicaid Services (CMS) Final
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