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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed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
M9 Biopharmaceutics Classification System-Based Biowaivers  Food and Drug Administration (FDA) Proposed
Major Depressive Disorder: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products   Food and Drug Administration (FDA) Proposed
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations  Food and Drug Administration (FDA) Proposed
Mouse Embryo Assay for Assisted Reproduction Technology Devices  Food and Drug Administration (FDA) Proposed
Multiple Endpoints in Clinical Trials Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
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