Expanded access to investigational drugs

New England Journal of Medicine

Volumn 372, Issue 15, 2015, Pages 1473-1474

  Lurie, Peter ^a   Chan Tack, Kirk M ^a   Woodcock, Janet ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

COMPASSIONATE USE; DOCUMENTATION; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; PATIENT PARTICIPATION; PHYSICIAN; PRIORITY JOURNAL; RISK FACTOR; DRUG APPROVAL; DRUG INDICATION; HEALTH CARE ACCESS; INSTITUTIONAL ETHICS; STANDARD; STRATEGIC PLANNING; BIOETHICS; HEALTH CARE DELIVERY; HEALTH CARE POLICY; LEGISLATION AND JURISPRUDENCE;

NEW DRUG;

BIOETHICAL ISSUES; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; HEALTH POLICY; HEALTH SERVICES ACCESSIBILITY; HUMANS;

EID: 84927131481     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc1501823     Document Type: Letter

References (4)

1. Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. N Engl J Med 2015;372:279-86.
2. Corieri C. Everyone deserves the right to try: empowering the terminally ill to take control of their treatment. Phoenix, AZ: Goldwater Institute, 2014 (https://www.heartland.org/sites/default/files/right-to-try-1.pdf).
3. Guidance for industry: individual patient expanded access applications: Form FDA 3926. Silver Spring, MD: Food and Drug Administration (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM432717.pdf).
4. Expanded access (compassionate use). Silver Spring, MD: Food and Drug Administration (http://www.fda.gov/expandedaccess).