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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
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause  Food and Drug Administration (FDA) Proposed
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
E22 General Considerations for Patient Preference Studies  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5483 documents.