Regulatory controls for direct-to-consumer genetic tests: a case study on how the FDA exercised its authority-Reference-Cited by-同舟云学术

Regulatory controls for direct-to-consumer genetic tests: a case study on how the FDA exercised its authority

Published:2017-07-03 Issue:3 Volume:36 Page:209-226
ISSN:1463-6778
Container-title:New Genetics and Society
language:en
Short-container-title:New Genetics and Society

Author:

Curnutte Margaret¹

Affiliation:

1. Baylor College of Medicine, Houston, TX, USA

Publisher

Informa UK Limited

Subject

Health Policy,Genetics,Health(social science),Issues, ethics and legal aspects

Link

https://www.tandfonline.com/doi/pdf/10.1080/14636778.2017.1354690

Reference68 articles.

1. 23andMe. 2014. Press Release. “Health Care and Genomics Industry Veteran, Kathy Hibbs, Esq. Joins 23andMe as Chief Legal and Regulatory Officer.” April 2. http://mediacenter.23andme.com/blog/exec_appointments_april_2014/.

2. 23andMe. 2015a. Press Release. “23andMe Genotypes One Millionth Customer.” June 18. http://mediacenter.23andme.com/blog/23andme-1million/.

3. 23andMe. 2015b. Press Release. “23andMe Granted Authorization by FDA to Market First Direct-to-Consumer Genetic Test under Regulatory Pathway for Novel Devices.” February 19. https://mediacenter.23andme.com/blog/fdabloomupdate/.

4. 23andMe. 2017. Blog Post. “Good News about Health Reports.” April 6. https://blog.23andme.com/news/good-news-about-health-reports/.

5. Alba, Dave. 2015. “23andMe Teams with Big Pharma to Find Treatments Hidden in Our DNA.” Wired. January 12. https://www.wired.com/2015/01/23andme-partners-big-pharma-find-treatments-hidden-genes/.

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