Impact of Expanded Access on FDA Regulatory Action and Product Labeling

Jarow Jonathan P.; Moscicki Richard

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Impact of Expanded Access on FDA Regulatory Action and Product Labeling

机译：扩大访问对FDA监管行动和产品标签的影响

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Background: The purpose of this study is to address concerns that expanded access may negatively impact the ultimate regulatory action and product labeling for new drugs.

机译：背景：本研究的目的是解决扩展访问可能对新药的最终监管行动和产品标签产生负面影响的疑虑。

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来源
《Therapeutic innovation & regulatory science.》 |2017年第6期|共3页
作者
Jarow Jonathan P.; Moscicki Richard;
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作者单位

US FDA Ctr Drug Evaluat &

Res Silver Spring MD USA;

US FDA Ctr Drug Evaluat &

Res Silver Spring MD USA;

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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
expanded access; new drug application; drug development; compassionate use;

机译：扩大访问;新药申请;药物发展;富有同情心的使用;
入库时间 2022-08-20 07:29:33

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专利

1. Impact of Expanded Access on FDA Regulatory Action and Product Labeling [J] . Jarow Jonathan P., Moscicki Richard Therapeutic innovation & regulatory science. . 2017,第6期

机译：扩大访问对FDA监管行动和产品标签的影响
2. Evaluating the impacts of the FDA's guidance for patient-reported outcomes (PROs) measures on clinical trial-based approved drug product labeling claims, 2006-2014 [J] . Andrew C. Palsgrove Clinical research and regulatory affairs. . 2015,第1a4期

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3. Cigarette graphic warning labels and smoking prevalence in Canada: a critical examination and reformulation of the FDA regulatory impact analysis [J] . Jidong Huang, Frank J Chaloupka, Geoffrey T Fong Tobacco control . 2014,第marasuppla1期

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4. IMPACTS OF THE EUROPEAN GAS DIRECTIVE ON GAS EXPORTERS - Recent experiences with the new Norwegian regulatory regime for accessing the natural gas transportation system [C] . Hans Jorgen DAHL, Sondre DYRLAND, Thor BJORKVOLL, NATO Advanced Research Workshop on Security of Natural Gas Supply through Transit Countries . 2004

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5. ECONOMIC ANALYSIS OF THE IMPACT OF IMPERFECT CONSUMER INFORMATION REGARDING PERFORMANCE OF TEXTILE PRODUCTS (LABELS, ECONOMIC LOSS, SHRINKAGE, UTILITY, ALLOCATIVE ERROR, SATISFACTION) [D] . SIEBEN, WANDA KAY ALPHIN. 1985

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6. Impact of Expanded Access on FDA Regulatory Action and Product Labeling [O] . Jonathan P. Jarow, Richard Moscicki -1

机译：扩大获取渠道对FDA法规行动和产品标签的影响
7. PNS410 DATA FROM EXPANDED ACCESS PROGRAMS: TREATMENT FIRST, COLLECTION SECOND. AN OVERVIEW OF FDA AND EMA REGULATORY APPROVALS. [O] . T. Polak, C.A. Uyl-de Groot, J. Van Rosmalen 2019

机译：PNS410来自扩展访问程序的数据：首先处理，收集秒。 FDA和EMA监管批准的概述。

Impact of Expanded Access on FDA Regulatory Action and Product Labeling

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