FDA Implementation of the Expanded Access Program in the United States

American Journal of Bioethics

Volumn 14, Issue 11, 2014, Pages 17-19

  Roth Cline, Michelle ^a   Nelson, Robert ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPASSIONATE USE; EVIDENCE BASED MEDICINE; HUMAN; INFORMATION PROCESSING; MORALITY; PATIENT; RESEARCH ETHICS;

COMPASSIONATE USE TRIALS; DATA COLLECTION; ETHICS, RESEARCH; EVIDENCE-BASED MEDICINE; HUMANS; MORAL OBLIGATIONS; PATIENTS;

EID: 84908017247     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2014.957418     Document Type: Note

References (3)

1. U.S. Food and Drug Administration. 1987. Part 312—Investigational new drug application, Sec 312.3 Definitions and interpretations, (b) Clinical investigation. Code of Federal Regulations Title 21. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3
2. U.S. Food and Drug Administration. 2009. Final rule 21, CFR Parts 312 and 316. Expanded access to investigational drugs for treatment use. Federal Register 74(155): 40900. Available at: http://www.gpo.gov/fdsys/pkg/FR-2009-08-13/pdf/E9-19005.pdf
3. Walker, M. J., W. A. Rogers, and V. Entwistle. 2014. Ethical justifications for access to unapproved medical interventions: An argument for (limited) patient obligations. American Journal of Bioethics 14(11): XX–XX.