1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved] 1312 管制物质的进口与出口 ...
1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES ...
205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS 206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE 207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING ...
The Food and Drug Administration (FDA) is set to start enforcing the requirements of theModernization of Cosmetics Regulation Act (MoCRA)on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action. MoCRA Background I...
Distributors or repackagers of products on the List are not identified. Because distributors or repackagers are not required to notify FDA when they shift their sources of supply from one approved manufacturer to another, it is n...
The FDA publishes a list of these NDC numbers and other information submitted. 但目录中不包括动物药品、血液制品或非最后销售形式的人类药品,如活性药品成分、进一步加工的药品、专门为私人标签经销商生产的药品或单独作为工具包一部分销售的药品或非单独销售或分发的组合产品The catalog does not include animal ...
ANDULTRASONICRADIATION-EMITTINGPRODUCTS 第K分章―[预留的]（SUBCHAPTERK―[RESERVED]） 第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTERL―REGULATIONSUNDERCERTAINOTHERACTSADMINISTEREDBYTHEFOODANDDRUGADMINISTRATION） 1210根据《联邦进口乳法》的规章REGULATIONSUNDERTHEFEDERALIMPORTMILKACT
FDA 2023年仿制药论坛(会议演讲PPT):CREATES 法案和涵盖产品授权.pdf,Overview: The CREATES Act and Covered Product Authorizations Sharon Coleman, JD, MA Senior Regulatory Counsel Office of Regulatory Policy FDA Center for Drug Evaluation and Research ➢
All changes should be highlighted or annotated within the Annual Report and should be included in the list of approved chemistry, manufacturing and control information described in Section IV of this document. SECTION II. DISTRIBUTION DATA [21 CFR 314.81(b)(2)(ii)] The firm should provide: A...
Retrospective Review List of Guidances for 1984, 1994, 2004, and 2014 1984 Final Guidances None 1994 Final Guidances Manufacturers And Initial Distributors Of Sharps Containers And Destroyers Used By Health Care Professionals Letter - Manufacturers, Distributors and Importers of Condom Products (included...