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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Financial Eligibility Verification Requirements and Flexibilities  Centers for Medicare & Medicaid Services (CMS) Final
State Medicaid Director Letter: Permanent Extension of Mandatory Medicaid State Plan Coverage of MAT/MOUD  Centers for Medicare & Medicaid Services (CMS) Final
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics  Food and Drug Administration (FDA) Proposed
2025 SSI, Spousal Impoverishment, and Medicare Savings Program Resource Standards  Centers for Medicare & Medicaid Services (CMS) Final
Guidance for Industry: FDA's Voluntary Qualified Importer Program  Food and Drug Administration (FDA) Final
Use of Unwinding-Related Strategies to Support Long-Term Improvements to State Medicaid Eligibility and Enrollment Processes  Centers for Medicare & Medicaid Services (CMS) Final
CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)  Food and Drug Administration (FDA) Final
CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1809-FC)  Centers for Medicare & Medicaid Services (CMS) Final
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3359 documents.

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