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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process  Food and Drug Administration (FDA) Final
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)  Food and Drug Administration (FDA) Final
CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews  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 #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease  Food and Drug Administration (FDA) Proposed
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3359 documents.

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