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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies: Considerations for Study Design   Food and Drug Administration (FDA) Proposed
CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media  Food and Drug Administration (FDA) Proposed
Developing Products for Weight Management Revision 1  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling  Food and Drug Administration (FDA) Proposed
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
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