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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
Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Investigational Device Exemption (IDE) Applications: Draft Guidance for Sponsors and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle  Food and Drug Administration (FDA) Final
Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI  Food and Drug Administration (FDA) Final
Draft Guidance for Industry: U.S.-Origin Statements on Seafood  Food and Drug Administration (FDA) Proposed
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing  Food and Drug Administration (FDA) Proposed
Advisory Opinion 26-02  Office of the General Counsel (OGC) Final
This Guidance Portal contains 11437 documents.