最近有客人问猫师奶,在yogi茶和GNC schiff这些保健品包装上,总看到一句话:These statements have not been evaluated by the FDA.These products are not intended to diagnose, treat, cure, or prevent any disease.(产品没有经过FDA检视,不能用于诊断、治疗、治愈或者预防任何疾病),产品没有经过FDA的的检视,是...
Michelson Laboratories provides complete nutritional labeling testing following the NLEA requirements needed to meet FDA regulations. From new food products to manufacturers, processors, and importers, we can help with requirements needs for nutritional labeling using the new label requirements. We offer st...
该许可要求提交对原始药物的生物等效性数据和其他相关资料。 食品添加剂许可(Food Additive Approval):适用于新的食品添加剂的许可申请。该许可要求提交对添加剂的安全性评估数据。 展开全文
1. 新药批准(New Drug Approval):FDA对新药的研发、临床试验数据和安全性进行评估,决定是否批准该药物上市销售。 2. 生物制品批准(Biologics Approval):FDA对生物制品,如生物类似药物、疫苗和细胞疗法等进行评估,确保其安全性、有效性和质量。 3. 医疗器械市场许可(Medical Device Marketing Clearance):FDA对医疗器械...
申请FDA(美国食品药品监督管理局)批准或许可涉及不同类型的产品和程序。下面是一般情况下针对不同产品的FDA申请过程的概述: 食品和饮料:食品和饮料的FDA申请一般是提交食品注册表(Food Facility Registration),该表用于注册食品生产、加工、包装或储存设施。此外,某些特定食品还需要提交食品添加剂申请(Food Additive Petiti...
2.2 PRODUCTS右侧上方PRODUCTS选项下包括八种类型产品,分别是Food食品、Drugs药品、Medical Devices医疗器械、Radiation-Emitting Products放射性产品、Vaccines, Blood, and Biologics疫苗、血液和生物制品、Animal and Veterinary动物和兽医制品、Cosmetics化妆品、Tobacco Products烟草。点击任意一项即可快速进入该产品的专栏,常用...
3. 医疗器械注册:根据FDA的要求,某些类别的医疗器械需要在市场销售之前进行注册。这包括一类、二类和三类医疗器械。注册过程可能涉及预市许可申请(如510(k))或申请获准(如Premarket Approval)。 对于其他类型的产品,例如化妆品和膳食补充剂,FDA通常不要求进行注册。但是,这些产品仍然需要符合FDA的规定和要求,以确保其安...
“prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FDC Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a ...
FDA extends approval of irradiation of food products to control infection. (Food and Drug Administration)Brown, Edwin W
eligible for the 503A bulks list because biological products subject to approval in a BLA under section 351 of the PHS Act are not eligible for the exemptions in section 503A of the FDC Act.15 No biological products subject to approval in a BLA will be considered for the 503A bulks list....