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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
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders  Food and Drug Administration (FDA) Final
Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers  Food and Drug Administration (FDA) Final
Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised): Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders  Food and Drug Administration (FDA) Final
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Final
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent: Guidance for Industry and Tobacco Retailers  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.