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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Healthy Adult Opportunity State Guidance  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Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
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
Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3337 documents.

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