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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products  Food and Drug Administration (FDA) Proposed
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers  Food and Drug Administration (FDA) Proposed
M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines  Food and Drug Administration (FDA) Proposed
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs  Food and Drug Administration (FDA) Final
CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process  Food and Drug Administration (FDA) Final
Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles  Food and Drug Administration (FDA) Proposed
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