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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports  Food and Drug Administration (FDA) Proposed
CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals  Food and Drug Administration (FDA) Proposed
Development and Submission of Near Infrared Analytical Procedures  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration  Food and Drug Administration (FDA) Proposed
Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry   Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Proposed
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