美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
1、FDA s Bar Code Label Requirementsfor Human Drug ProductsGeneral Questions Related to Drugs and BiologicsFDA QuestionHDMA Response1. Which medical products should carry a bar code? For example, should all prescription and over-the-counter (OTC) drugs be bar coded? Should blood products and ...
□ 医疗机构中的再加工医疗器械:验证方法和标识Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling □ 医疗器械患者标识指南Guidanceon Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers □ 器械建议的标识要求Labeling requirements from Device Advice ■...
Because you failed to correct repeat violations, we strongly recommend engaging a consultant as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management ...
l“abeling A drug product is misbranded if its abeling is false or misleading in any particular is false or misleading in any particular [502(a)][502(a)] ”and fails to haveand fails to have adequate“adequate directions for use [502(f)]. ” Labeling Requirements Labeling Requirements ?
April 15, 2008 Labeling Labeling Overview Overview Jeanne M. Delasko, RN, MS Jeanne M. Delasko, RN, MS Label Initiatives Specialist Label Initiatives Specialist Study Endpoints and Label Development Study Endpoints and Label Development Office of New Drugs, CDER, FDA Office of New Drugs, CDER, ...
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the ...
3.GENERALFOODLABELINGREQUIREMENTS5 4.NAMEOFFOOD7 Juices 5.NETQUANTITYOFCONTENTSSTATEMENTS14 6.INGREDIENTLISTS17 Colors FoodAllergenLabeling 7.NUTRITIONLABELING25 General NutrientDeclaration ProductswithSeparatelyPackagedIngredients/AssortmentsofFoods LabelFormats/Graphics ...
(under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act), and those required to self-identify under GDUFA submit information separately to the respective systems. Each system p...
器械建议的标识要求/ Labelingrequirements from Device Advice ---完--- 医疗器械从业者Medical Device Practitioner “专注、专业、分享、成长":专注医疗器械行业领域,学习、分享专业资讯、知识、技能,促进医疗器械从业者自我成长与提升。欢迎医疗器械行业的研发、注册、法规、体系、品质、工艺、生产、采购、HR等医疗器械...