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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Arsenic in Apple Juice   Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Best Practices for Convening a GRAS Panel  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations  Food and Drug Administration (FDA) Proposed
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