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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
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Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed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Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed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
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers: Guidance for Industry Q&A  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.