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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products  Food and Drug Administration (FDA) Proposed
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 3315 documents.

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