Prevalence of Publicly Available Expanded Access Policies-Reference-Cited by-同舟云学术

Prevalence of Publicly Available Expanded Access Policies

Published:2018-03-23 Issue:5 Volume:104 Page:1016-1021
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Jung Emily¹²,Zettler Patricia J.³,Kesselheim Aaron S.²

Affiliation:

1. Faculty of Arts and Sciences; Harvard University; Cambridge Massachusetts USA

2. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine; Brigham and Women's Hospital and Harvard Medical School; Boston Massachusetts USA

3. Center for Law, Health & Society, Georgia State University College of Law; Atlanta Georgia USA

Funder

Laura and John Arnold Foundation

Engelberg Foundation

Harvard Program in Therapeutic Science

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.996/fullpdf

Reference17 articles.

1. Practical, legal, and ethical issues in expanded access to investigational drugs;Darrow;N. Engl. J. Med.,2015

2. The strange allure of state 'Right-to-Try' laws;Zettler;JAMA Intern. Med.,2014

3. Fed. Regist 74 40900 45 2009

4. U.S. Government Accountability Office https://www.gao.gov/products/GAO-17-564 2017

5. Huneycutt , B. http://avalere.com/expertise/life-sciences/insights/manufacturers-compassionate-use-policies-companies-with-posted-policies-mor 2017

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1. Stem cells, cell therapies, and bioengineering in lung biology and disease 2021;American Journal of Physiology-Lung Cellular and Molecular Physiology;2022-09-01

2. ClinicalTrials.gov as a Source of Information About Expanded Access Programs: Cohort Study;Journal of Medical Internet Research;2021-10-28

3. Implementation of 21st Century Cures Act Expanded Access Policies Requirements;Clinical Pharmacology & Therapeutics;2021-09-12

4. ClinicalTrials.gov as a Source of Information About Expanded Access Programs: Cohort Study (Preprint);2021-01-02

5. Ethics framework for treatment use of investigational drugs;BMC Medical Ethics;2020-11-18