Food and Drug Administration Drug Approval Process A History and Overview

Williams Christopher Ty

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Food and Drug Administration Drug Approval Process A History and Overview

机译：食品药品监督管理局药品审批流程的历史和概述

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In this article, the processing of investigational and new drug applications is described and the standard and expedited review processes are examined. The efforts of the US Food and Drug Administration to ensure greater agency transparency and fiscal responsibility and intensify oversight during the drug development and approval process are reviewed. Often attributed to a decrease in the number of uninsured adults, both the increase in prescription drug sales and the high costs associated with bringing a new drug to market highlight the necessity for a streamlined and cost-effective process to deliver these drugs safely and effectively.

机译：在本文中，描述了研究和新药申请的处理过程，并对标准和快速审查程序进行了审查。审查了美国食品药物管理局（FDA）为确保更大的机构透明度和财政责任以及在药物开发和批准过程中加强监督的努力。通常归因于未投保成年人的数量减少，处方药销售的增加以及与将新药推向市场相关的高成本都凸显了采用简化且具有成本效益的过程安全有效地运送这些药物的必要性。

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《The Nursing Clinics of North America》 |2016年第1期|共12页
作者
Williams Christopher Ty;
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原文格式 PDF
正文语种 eng
中图分类护理学;
关键词
Food and Drug Administration; Drug review; Drug approval; Expedited reviews;

机译：食品药品监督管理局;药品审查;药品批准;加急审查;

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1. Food and Drug Administration Drug Approval Process A History and Overview [J] . Williams Christopher Ty The Nursing Clinics of North America . 2016,第1期

机译：食品药品监督管理局药品审批流程的历史和概述
2. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology [J] . Ning Yang-Min, Maher V. Ellen Urologic oncology . 2015,第3期

机译：食品药品监督管理局药品和放射性药物开发和批准程序：泌尿科肿瘤学治疗
3. Has the food and drug administration changed the drug approval process? [J] . Somberg JC American journal of therapeutics . 2011,第3期

机译：食品药品监督管理局是否更改了药品批准程序？
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. The US Food and Drug Administrations tentative approval process and the global fight against HIV [O] . Harinder Singh Chahal, Jeffrey S Murray, Martin Shimer, 2017

机译：美国食品药品监督管理局的初步批准程序和全球抗击艾滋病毒的斗争
7. The US Food and Drug Administration Cardiorenal Advisory Panel and the Drug Approval Process [O] . Dan M. Roden, Robert Temple, Md Robert Temple 2015

机译：美国食品和药物管理局心肾咨询小组和药物批准程序

Food and Drug Administration Drug Approval Process A History and Overview

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