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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry  Food and Drug Administration (FDA) Final
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Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
This Guidance Portal contains 3320 documents.

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