FDA CDRH在2023财年资源允许的情况下会发布的指南文件 B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2023 Final Guidance Topics • Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations 过氧化氢隐形眼镜护理产品-患者标签建议 ...
The US Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetic product facility registrations and productlistingsare now included within the SPL framework. The ...
2023, the USDA released aproposed ruleto help define what is meant when a food product is a “Product of USA” or “Made in the USA.” Currently, Food Safety and Inspection Service (FSIS) regulated
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products” and corresponding Notice of Availa...
FDA Releases Draft CPG on Major Food Allergen Labeling and Cross-ContactMay 24th, 2023 On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross...
Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not ...
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and ...
美国FDA 指导原则 药品生产用药品申请中提交证明文件的指南 英文原版.pdf,Center for Drugs and Biologic8 Food and Drug Administration Department of Health andHuman Services February 1987 Ebr further informatim regarding the guideline please ccmtact: FoodandD
Are You Ready for the FDA Food Labeling Rule? (the FDA Has Released A Compliance Guide)Radus, Alexander
All currently used labeling, including a representative sample of package labels. This should include all package inserts and examples of the immediate container labels. It may be useful to include labels of distributors. Samples of all labeling which has undergone a change during the reporting ...