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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VI GRAS Notices  Food and Drug Administration (FDA) Proposed
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Food and Drug Administration (FDA) Proposed
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data  Food and Drug Administration (FDA) Proposed
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels  Food and Drug Administration (FDA) Proposed
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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