用于诊断和监测的体内放射性药物法规——美国食品药品监督管理局。拟议规则。

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring--FDA. Proposed rule.

出版信息

Fed Regist. 1998 May 22;63(99):28301-9.

Abstract

The Food and Drug Administration (FDA), in response to the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA), is proposing to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The proposed regulations would describe certain types of indications for which FDA may approve diagnostic radiopharmaceuticals. The proposed rule also would include criteria that the agency would use to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act.

摘要

美国食品药品监督管理局（FDA）根据1997年《食品药品管理现代化法案》（FDAMA）的要求，提议修订药品和生物制品法规，增加相关条款，以明确用于疾病诊断或监测的体内放射性药物的评估和审批。拟议法规将描述FDA可能批准诊断用放射性药物的某些适应症类型。拟议规则还将包括该机构根据《联邦食品、药品和化妆品法案》（该法案）和《公共卫生服务法案》（PHS法案）评估诊断用放射性药物安全性和有效性时将使用的标准。

相似文献

1

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring--FDA. Proposed rule.用于诊断和监测的体内放射性药物法规——美国食品药品监督管理局。拟议规则。

Fed Regist. 1998 May 22;63(99):28301-9.

2

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring; extension of comment period--FDA. Proposed rule; extension of comment period.用于诊断和监测的体内放射性药物法规；意见征求期延长——美国食品药品监督管理局。拟议规则；意见征求期延长。

Fed Regist. 1998 Aug 3;63(148):41219-20.

3

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule.用于诊断和监测的体内放射性药物法规。美国卫生与公众服务部食品药品监督管理局。最终规则。

Fed Regist. 1999 May 17;64(94):26657-70.

4

Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.撤销正电子发射断层扫描药品相关规定——美国食品药品监督管理局。最终规则；撤销。

Fed Regist. 1997 Dec 19;62(244):66522.

5

Removal of regulations regarding certification of antibiotic drugs; companion document to direct final rule--FDA. Proposed rule.取消抗生素药物认证相关规定；直接最终规则的配套文件——美国食品药品监督管理局。拟议规则。

Fed Regist. 1998 May 12;63(91):26127-9.

6

Removal of regulations regarding certification of drugs composed wholly or partly of insulin; companion document to direct final rule--FDA. Proposed rule.取消关于全部或部分由胰岛素组成的药物认证的规定；直接最终规则的配套文件——美国食品药品监督管理局。拟议规则。

Fed Regist. 1998 May 13;63(92):26690-3.

7

Removal of regulations regarding certification of antibiotic drugs--FDA. Direct final rule.取消关于抗生素药物认证的规定——美国食品药品监督管理局。直接最终规则。

Fed Regist. 1998 May 12;63(91):26066-9.

8

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule.因安全或有效性原因已被撤出或退市的药品清单——美国食品药品监督管理局。拟议规则。

Fed Regist. 1998 Oct 8;63(195):54082-9.

9

Medical devices; humanitarian use of devices; companion to direct final rule--FDA. Proposed rule.医疗器械；器械的人道主义用途；直接最终规则的配套文件——美国食品药品监督管理局。拟议规则。

Fed Regist. 1998 Apr 17;63(74):19196-200.

10

Removal of regulations regarding certification of drugs composed wholly or partly of insulin--FDA. Direct final rule.撤销关于全部或部分由胰岛素组成的药物认证的规定——美国食品药品监督管理局。直接最终规则。

Fed Regist. 1998 May 13;63(92):26694-9.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

文档翻译

学术文献翻译模型，支持多种主流文档格式。