Characterizing expanded access and compassionate use programs for experimental drugs

Author:

Miller Jennifer E.ORCID,Ross Joseph S.,Moch Kenneth I.,Caplan Arthur L.

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference22 articles.

1. White House. Readout of the vice president’s meeting with right to try advocates. https://www.whitehouse.gov/the-press-office/2017/02/07/readout-vice-presidents-meeting-right-try-advocates . Accessed 15 Feb 2017.

2. U.S. Food and Drug Administration. Expanded access INDs and protocols 2009–2015. http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm443572.htm . Accessed 15 Feb 2017.

3. U.S. Food and Drug Administration. Expanded access (compassionate use) https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm . Accessed 23 June 2017.

4. U.S. Food and Drug Administration. Charging for investigational drugs under an IND—questions and answers, guidance for industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351264.pdf Accessed 23 June 2017.

5. Jarow JP, Lurie P, Ikenberry SC, Lemery S. Overview of FDA’s expanded access program for investigational drugs. Ther Innov Regul Sci. 2017;51(2):177–9. doi: 10.1177/2168479017694850 .

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