美国食品药品监督管理局的早期准入和快速通道批准计划：它们的成效如何？ - Suppr

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The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?

作者信息

Shulman S R, Brown J S

机构信息

Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.

出版信息

Food Drug Law J. 1995;50(4):503-31.

PMID:10343017

Abstract

摘要

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The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?

作者信息

Shulman S R, Brown J S

机构信息

Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.

出版信息

Food Drug Law J. 1995;50(4):503-31.

PMID:10343017

Abstract

摘要

相似文献

The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?

Food Drug Law J. 1995;50(4):503-31.

FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.

Food Drug Law J. 2009;64(1):183-223.

Access before approval--a right to take experimental drugs?

N Engl J Med. 2006 Aug 3;355(5):437-40. doi: 10.1056/NEJMp068132.

They are from the government and they really are here to help you.

J Clin Pharmacol. 2008 Feb;48(2):142-3. doi: 10.1177/0091270007313559.

Communicating with the FDA: the "third rail" of a new model for drug development.

J Clin Pharmacol. 2008 Feb;48(2):144-5. doi: 10.1177/0091270007313560.

Charging for investigational drugs under an investigational new drug application. Final rule.

Fed Regist. 2009 Aug 13;74(155):40871-900.

Potential pathways for abbreviated approval of generic biologics under existing law and proposed reforms to the law.

Food Drug Law J. 2007;62(1):77-137.

Expanded access to investigational drugs for treatment use. Final rule.

Fed Regist. 2009 Aug 13;74(155):40900-45.

Individual patient treatment use of unapproved drugs: a new option for the seriously ill.

J Pain Palliat Care Pharmacother. 2010 Mar;24(1):19-22. doi: 10.3109/15360280903583057.

A new history and discussion of 180-day exclusivity.

Food Drug Law J. 2009;64(2):335-90.

引用本文的文献

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

BMJ. 2015 Sep 23;351:h4633. doi: 10.1136/bmj.h4633.

The US orphan drug programme 1983-1995.

Pharmacoeconomics. 1997 Sep;12(3):312-26. doi: 10.2165/00019053-199712030-00004.