Papers & Publications

Download these!

Remdesivir EUA Letter

Author – FDA

Right To Try Law

Author – United States

FDA Report on Trial Inclusivity

Author – FDA

Expanded Access Cost Recovery Guidance

Author – FDA

Single-Patient “Compassionate Use” Guidance

Author – FDA
FDA Report on TriExpanded Access Treatment IND Guidanceal Inclusivity
Author – FDA

2009 Expanded Access Final Rule

Author – Federal Register

2007 CDC Memo Introducing US Emergency Use Authorization

Author – S. Nightingale et al.
Author – FDA

Copyrighted by Publisher, but most are free to download:

“Scaling Compassion”

BioCentury, November 2015

“Crowdsourcing Clinical Trials”

Minnesota Law Review, January 2014

“Global Access Programs: A Collaborative Approach for Effective Implementation and Management”

Ainge, Aitken, Corbett, De-Keyzer
Pharmaceutical Magazine, March 2015

Envisioning a Transformed Clinical Trials Enterprise in the United States; Establishing an Agenda for 2020 Institute of Medicine

National Academies Press,
November 2012

Artificial Intelligence, Drug Repurposing, and Peer Review

Levin, et al.
Nature Biotechnology, September 2020

Results from Lepatinib (Tykerb) EAP in HER+ Breast Cancer

Capri, et al.
Oxford University Press, March 2010

Results of Linezolid EAP in Staphylococcus Aureus Infection

Moise, Forrest, Birmingham, Schentag
Journal of Antimicrobial Chemotherapy, August 2002

“Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs”

Darrow, Sarpatwari, Avorn, Kessleheim
NEJM, January 2015

Results of Sorafenib (Nexavar) EAP in Kidney Cancer

Stadler, et al.
Cancer, March 2010

“Reevaluating Eligibility Criteria -Balancing Patient Protection and Participation in Oncology Trials”

Beaver, Ison, Pazdur
NEJM, April 2017

“The New Marketplace of Health Care: Impacts and Incentives of Payment Reform”

Massachusetts Medical Society
NEJM Catalyst, 2016-2017

Original 1988 FDA Memo on Regulations for Sponsored Expanded Access Programs (EAPs)

Young, Norris, Levitt, Nightingale
JAMA, April 1988

10-Year FDA Case Review of EAPs and their Impact on Clinical Development

Jarow, Lemery, Bugin, Khozin, Moscicki
Therapeutic Innovation and Regulatory Science, June 2016