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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials  Food and Drug Administration (FDA) Proposed
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry  Food and Drug Administration (FDA) Proposed
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input  Food and Drug Administration (FDA) Proposed
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