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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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
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
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