Abbreviations and Acronyms:FDA (Food and Drug Administration), IND (Investigational New Device), LMIC (Low- and middle-income country)
- Taylor M.
- Taylor M.
- Taylor M.
- Office of Inspector General
Why Conduct Trials Outside the United States?
Concerns: Ethics and Evidence of Quality
Laws Governing Offshore Pharmaceutical Trials
- U.S. Food and Drug Administration
Challenges and Potential Solutions
- Offshore human testing of herpes vaccine stokes debate over U.S. safety rules. Kaiser Family Foundation.Published August 28, 2017. Accessed March 30, 2018)
- Participants in rogue herpes vaccine research take legal action. Kaiser Family Foundation.Published March 13, 2018. Accessed March 30, 2018)
- Challenges to FDA’s ability to monitor and inspect foreign clinical trials. June 2010.Published June 2010. Accessed March 30, 2018)
- Innovation in the pharmaceutical industry: new estimates of R&D costs.J Health Econ. 2016; 47: 20-33
- Rebuilding the R&D engine in big pharma.Harv Bus Rev. 2008; 86 (72-76, 128): 68-70
- FDA perspective on international clinical trials. U.S. Food & Drug Administration.
- Can the FDA improve oversight of foreign clinical trials? closing the information gap and moving towards a globalized regulatory scheme.Ann Health Law. 2012; 21 (4 p preceding i): 493-511
- Ethical and scientific implications of the globalization of clinical research.N Engl J Med. 2009; 360: 816-823
- Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries.JAMA. 1994; 271: 295-301
- Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests.BMJ. 2006; 332: 1233
- Health and ethical consequences of outsourcing pivotal clinical trials to Latin America: a cross-sectional, descriptive study.PLoS One. 2016; 11: e0157756
21 C.F.R. § 314.106.
21 C.F.R. § 312.120.
- Guidance for industry and FDA staff: FDA acceptance of foreign clinical studies not conducted under an IND, Frequently asked questions.Published March 2012. Accessed March 30, 2018)
Potential Competing Interests: The authors report no competing interests.
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