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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
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Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed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Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed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
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff  Food and Drug Administration (FDA) Final
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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