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Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
- Source :
- New England Journal of Medicine. 372:279-286
- Publication Year :
- 2015
- Publisher :
- Massachusetts Medical Society, 2015.
-
Abstract
- The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.
- Subjects :
- Drug Industry
education
MEDLINE
Pharmacology
History, 21st Century
Health Services Accessibility
Humans
Medicine
Bioethical Issues
Product (category theory)
Drug Approval
Drug industry
health care economics and organizations
Ethical issues
United States Food and Drug Administration
business.industry
Health Policy
Historical Article
Drugs, Investigational
General Medicine
History, 20th Century
United States
Expanded access
Investigational Drugs
Government Regulation
Engineering ethics
business
Subjects
Details
- ISSN :
- 15334406 and 00284793
- Volume :
- 372
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine
- Accession number :
- edsair.doi.dedup.....ef5c4aef3a8b0211a37bc6e2dd8735dc