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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics 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Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  Food and Drug Administration (FDA) Proposed
Good ANDA Submission Practices 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
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  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Draft Guidance for Industry: Regulatory Submissions to OFAS, Part I Introduction  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  Food and Drug Administration (FDA) Proposed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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