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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Replacement Designee Selections for Fiscal Year 2022 (PDF)  Administration for Children and Families (ACF) Final
CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs  Food and Drug Administration (FDA) Final
CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs  Food and Drug Administration (FDA) Final
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Guidance for Industry: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.