Postmarket Reporting Detailed In Draft Combo Product Rule

April Hollis

首页> 外文期刊>Washington Drug Letter >Postmarket Reporting Detailed In Draft Combo Product Rule

【24h】

Postmarket Reporting Detailed In Draft Combo Product Rule

机译：组合产品规则草案中详细介绍了上市后报告

获取原文

获取原文并翻译 | 示例

获取外文期刊封面封底 >>

开具论文收录证明 >>

文献代查 >>

页面导航

摘要
著录项
相似文献
相关主题

摘要

Sponsors of combination products should follow the postmarket reporting requirements of the type of application used to get the FDA's approval or clearance, as well as provide additional reports for the product's constituent parts, under a proposed rule issued by the FDA.rnThe additional reports would be necessary only if the original approval or clearance did not require them or if they were required by rules for the constituent part at times earlier than those mandated by the original approval or clearance.

机译：组合产品的保荐人应遵循获得FDA批准或批准的申请类型的上市后报告要求，并根据FDA发布的拟议规则提供产品组成部分的其他报告。仅当原始批准或许可中没有要求时，或者在组成部分的规则中早于原始批准或许可所要求的时间时才需要。

著录项

来源
《Washington Drug Letter》 |2009年第39期|5-6|共2页
作者
April Hollis;
展开▼
作者单位

展开▼
收录信息
原文格式 PDF
正文语种 eng
中图分类
关键词

相似文献

外文文献
中文文献
专利

1. DRAFT RULE WILL REQUIRE TOXIC REPORTING FOR FINISHED WOOD PRODUCTS [J] . Inside EPA's environmental policy alert . 2009,第7期

机译：规则草案将需要对成品木制品进行有毒物质报告
2. Retrospective analysis of the immunotoxic effects of plant protection products as reported in the Draft Assessment Reports for their peer review at EU level [J] . Ian Dewhurst, Lata Koshy, Scott Samuels, EFSA supporting publications . 2015,第4期

机译：评估报告草案中所报告的植物保护产品的免疫毒性作用的回顾性分析，供其在欧盟范围内进行同行评审
3. Nanomaterials Users Fault Draft EPA Reporting Guide, Call For Rule Repeal [J] . Dave Reynolds Entsorga Magazin . 2017,第12期

机译：纳米材料用户故障EPA报告草稿，要求废除规则
4. Report of the Technical Consultation to Draft a Legally-binding Instrument on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated Fishing. Rome, 23-27 June 2008, 26 [C] . Technical Consultation to Draft a Legally-binding Instrument on Port State Measures to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated . 2009

机译：技术磋商会起草法律约束力的港口国家措施的报告，以防止，阻止和消除非法，未报告和不受管制的捕捞。罗马，2008年6月23日至27日，26日
5. Effects of Principles vs. Rules Based Accounting Standards and Expanded Auditor Reporting on Investors' Perceptions of Management's Reporting Credibility. [D] . Ozlanski, Michael Edward. 2013

机译：基于原则与规则的会计准则和扩大的审计师报告对投资者对管理层报告信誉的看法的影响。
6. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: Drug Products Including Biological Products that Contain Nanomaterials [O] . Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, -1

机译：AAPS指导论坛关于FDA工业指导草案的报告：包含纳米材料的药物产品包括生物产品
7. Proposals for Council decisions on a Community position on an amendment to Protocol 4 on the definition of the concept of "originating products" and methods of administrative cooperation set out in the Europe Agreement between the European Communities and Bulgaria, the Czech Republic, Poland, Hungary, the Slovak Republic and Romania. Proposals for Council decisions on a Community position on an amendment to Protocol 3 on the definition of the concept of "originating products" and methods of administrative cooperation set out in the Europe Agreement between the European Communities and the Republic of Estonia, the Republic of Latvia and the Republic of Lithuania. Proposal for a Council decision on a Community position on an amendment to Protocol 4 on the definition of the concept of "originating products" and methods of administrative cooperation set out in the Interim Agreement on trade and trade related matters between the European Communities and the Republic of Slovenia. Draft decision N° .../ of the EC-Switzerland Joint Committee amending Protocol 3 to the Agreement between the European Economic Community and the Swiss Confederation concerning the definition of the concept of "originating products" and methods of administrative cooperation. Draftdecision N° .../ of the EC-Norway Joint Committeeamending Protocol 3 to the Agreement between the European Economic Community and the Kingdom of Norway concerning the definition of the concept of "originating products" and methods of administrative cooperation. Draftdecision N° .../ of the EC-Iceland Joint Committeeamending Protocol 3 to the Agreement between the European Economic Community and the Republic of Iceland concerning the definition of the concept of "originating products" and methods of administrative cooperation. Draft decision N° .../ of the EEA Joint Committee No .. amending Protocol 4 to the EEA Agreement on rules of origin. COM (98) 389 final, 17 July 1998 [O] . 1998

机译：关于欧洲共同体与保加利亚，捷克共和国，波兰，匈牙利之间的欧洲协定中规定的关于“原产地”概念和行政合作方法的定义的关于共同体关于共同体立场的决定的提案，斯洛伐克共和国和罗马尼亚。关于欧洲共同体与爱沙尼亚共和国，拉脱维亚共和国之间的欧洲协定中规定的关于“原产地”概念和行政合作方法的定义的关于共同体关于共同体立场的决定的提案和立陶宛共和国。关于欧洲共同体与共和国之间关于贸易和贸易相关事项的临时协定中规定的关于“原产地”概念和行政合作方法的定义的关于共同体关于共同体立场的立场的决定的提案斯洛文尼亚。 EC-switzerland联合委员会的决定草案N°...... /修订欧洲经济共同体与瑞士联邦之间关于“原产地”概念和行政合作方法的定义的第3号议定书。草案欧共体 - 挪威联合委员会的决定修订欧洲经济共同体与挪威王国之间关于“原产地”概念和行政合作方法的定义的第3号议定书。草案欧共体 - 冰岛联合委员会的决定修订欧洲经济共同体与冰岛共和国之间关于“原产地”概念和行政合作方法的定义的第3号议定书。欧洲经济区联合委员会第......号决定草案，修订“欧洲经济区原产地规则协定”第4号议定书。 COm（98）389决赛，1998年7月17日
8. Product Category Rules (PCR) for Building Products on an International Market. A Draft Based on Life Cycle Assessment (LCA) Methodology in Compliance with ISO 14025 [R] . Erlandsson, M., Lindfors, L. G., Ryding, S. O. 2005

机译：建筑产品在国际市场上的产品类别规则（pCR）。基于符合IsO 14025的生命周期评估（LCa）方法的草案

Postmarket Reporting Detailed In Draft Combo Product Rule

摘要

著录项

相似文献

相关主题

期刊订阅