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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials  Food and Drug Administration (FDA) Proposed
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry  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Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling  Food and Drug Administration (FDA) Proposed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
eCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part I Introduction  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  Food and Drug Administration (FDA) Proposed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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