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Literature DB >> 20920664

Understanding FDA regulation of DTC genetic tests within the context of administrative law.

Abstract

How the FDA should regulate direct-to-consumer genetic tests is fiercely contested. Passing a rule or issuing an order is only one down in the series. There is more to the regulatory game.

Mesh：

Year: 2010 PMID： 20920664 PMCID： PMC2948799 DOI： 10.1016/j.ajhg.2010.09.003

Source DB: PubMed Journal: Am J Hum Genet ISSN： 0002-9297 Impact factor: 11.025

11 in total

1. Preparing for a consumer-driven genomic age.

Authors: James P Evans; David C Dale; Cathy Fomous
Journal: N Engl J Med Date: 2010-08-18 Impact factor: 91.245

2. Which way for genetic-test regulation? Assign regulation appropriate to the level of risk.

Authors: Gail Javitt
Journal: Nature Date: 2010-08-12 Impact factor: 49.962

3. Which way for genetic-test regulation? Leave test interpretation to specialists.

Authors: Arthur L Beaudet
Journal: Nature Date: 2010-08-12 Impact factor: 49.962

4. Genetics. The illusive gold standard in genetic ancestry testing.

Authors: Sandra Soo-Jin Lee; Sandra Soo-Jin Lee; Deborah A Bolnick; Troy Duster; Pilar Ossorio; Kimberly Tallbear
Journal: Science Date: 2009-07-03 Impact factor: 47.728

Review 5. The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

Authors: Stuart Hogarth; Gail Javitt; David Melzer
Journal: Annu Rev Genomics Hum Genet Date: 2008 Impact factor: 8.929

6. In search of a coherent framework: options for FDA oversight of genetic tests.

Authors: Gail H Javitt
Journal: Food Drug Law J Date: 2007 Impact factor: 0.619

7. Direct-to-consumer personal genome testing: the problem is not ignorance--it is market failure.

Authors: Christopher F C Jordens; Ian H Kerridge; Gabrielle N Samuel
Journal: Am J Bioeth Date: 2009 Impact factor: 11.229

Review 8. The regulation of direct-to-consumer genetic tests.

Authors: Jane Kaye
Journal: Hum Mol Genet Date: 2008-10-15 Impact factor: 6.150

Review 9. Left to their own devices: breakdowns in United States medical device premarket review.

Authors: Jonas Zajac Hines; Peter Lurie; Eunice Yu; Sidney Wolfe
Journal: PLoS Med Date: 2010-07-13 Impact factor: 11.069

10. Risks of presymptomatic direct-to-consumer genetic testing.

Authors: Justin P Annes; Monica A Giovanni; Michael F Murray
Journal: N Engl J Med Date: 2010-08-18 Impact factor: 91.245

10 in total

1. Communication about DTC testing: commentary on a 'family experience of personal genomics'.

Authors: Anna Middleton
Journal: J Genet Couns Date: 2012-01-06 Impact factor: 2.537

2. Legislation on direct-to-consumer genetic testing in seven European countries.

Authors: Pascal Borry; Rachel E van Hellemondt; Dominique Sprumont; Camilla Fittipaldi Duarte Jales; Emmanuelle Rial-Sebbag; Tade Matthias Spranger; Liam Curren; Jane Kaye; Herman Nys; Heidi Howard
Journal: Eur J Hum Genet Date: 2012-01-25 Impact factor: 4.246

Understanding FDA regulation of DTC genetic tests within the context of administrative law.

1. Preparing for a consumer-driven genomic age.

2. Which way for genetic-test regulation? Assign regulation appropriate to the level of risk.

3. Which way for genetic-test regulation? Leave test interpretation to specialists.

4. Genetics. The illusive gold standard in genetic ancestry testing.

Review 5. The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

6. In search of a coherent framework: options for FDA oversight of genetic tests.

7. Direct-to-consumer personal genome testing: the problem is not ignorance--it is market failure.

Review 8. The regulation of direct-to-consumer genetic tests.

Review 9. Left to their own devices: breakdowns in United States medical device premarket review.

10. Risks of presymptomatic direct-to-consumer genetic testing.

1. Communication about DTC testing: commentary on a 'family experience of personal genomics'.

2. Legislation on direct-to-consumer genetic testing in seven European countries.

3. Direct-to-consumer testing: if consumers are not anxious, why are policymakers?

4. Counterpoint: Do not opine before it's time.

5. Point: Are we prepared for the future doctor visit?

6. Recent developments in health care law: culture and controversy.

7. Direct to consumer genetic testing-law and policy concerns in Ireland.

8. The Federal Trade Commission and Consumer Protections for Mobile Health Apps.

9. Direct-to-consumer genetic testing: a comprehensive view.

10. Field of genes: an investigation of sports-related genetic testing.