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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology  Food and Drug Administration (FDA) Proposed
Healthy Adult Opportunity State Guidance  Centers for Medicare & Medicaid Services (CMS) Final
2025 Federal Poverty Level Standards  Centers for Medicare & Medicaid Services (CMS) Final
Section 5112 Requirement for all States to Provide Continuous Eligibility to Children in Medicaid and CHIP under the Consolidated Appropriations Act, 2023: Updated SHO and FAQs  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process  Food and Drug Administration (FDA) Final
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
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
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