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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry  Food and Drug Administration (FDA) Proposed
Major Depressive Disorder: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling  Food and Drug Administration (FDA) Proposed
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Upper Facial Lines: Developing Botulinum Toxin Drug Products  Food and Drug Administration (FDA) Proposed
Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Draft Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Draft Instructions for Completing the Medicare Advantage Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) Proposed
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