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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Major Depressive Disorder: 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
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
M9 Biopharmaceutics Classification System-Based Biowaivers  Food and Drug Administration (FDA) Proposed
M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes  Food and Drug Administration (FDA) Proposed
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  Food and Drug Administration (FDA) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
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