23andMe and the FDA

New England Journal of Medicine

Volumn 370, Issue 11, 2014, Pages 985-988

  Annas, George J ^a   Elias, Sherman ^b  

^a BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; CONSUMER HEALTH INFORMATION; DNA DETERMINATION; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; GENETIC PRIVACY; GENETIC SCREENING; GENOME ANALYSIS; GOVERNMENT REGULATION; HEALTH HAZARD; INFORMED CONSENT; LEGAL PROCEDURE; MARKETING; PRIORITY JOURNAL; PROGNOSIS; SHORT SURVEY;

GENETIC TESTING; GENOME, HUMAN; GOVERNMENT REGULATION; HUMANS; INFORMED CONSENT; MARKETING; POLYMORPHISM, SINGLE NUCLEOTIDE; PRIVACY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896788068     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1316367     Document Type: Article

References (5)

1. Paving the way for personalized medicine: FDA's role in a new era of medical product development. Silver Spring, MD: Food and Drug Administration, October 2013 (http://www.fda.gov/downloads/scienceresearch/specialtopics/ personalizedmedicine/ucm372421.pdf).
2. Collins FS, Hamburg MA. First FDA authorization for next-generation sequencer. N Engl J Med 2013;369:2369-71.
3. Glantz L, Roche P, Annas GJ. Rules for donations to tissue banks - what next? N Engl J Med 2008;358:298-303.
4. Anticipate and communicate: ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts. Washington, DC: Presidential Commission for the Study of Bioethical Issues, December 2013 (http://bioethics.gov/sites/default/files/ FINALAnticipateCommunicate-PCSBI-0.pdf).
5. Wolf SM, Annas GJ, Elias S. Point-counterpoint: patient autonomy and incidental findings in clinical genomics. Science 2013;340:1049-50.