The FDA and genomic tests--getting regulation right

Affiliations

¹ From the Center for Biotechnology and Law, University of Houston Law Center, Houston (B.J.E.); and the Departments of Bioethics and Humanities (W.B.), Medicine (Medical Genetics) (G.P.J.), and Genome Sciences (G.P.J.), University of Washington, Seattle.

Barbara J Evans et al. N Engl J Med. 2015.

. 2015 Jun 4;372(23):2258-64.

doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.

¹ From the Center for Biotechnology and Law, University of Houston Law Center, Houston (B.J.E.); and the Departments of Bioethics and Humanities (W.B.), Medicine (Medical Genetics) (G.P.J.), and Genome Sciences (G.P.J.), University of Washington, Seattle.

No abstract available

Comment in

The FDA and genetic testing.
Litwack ED, Mansfield E, Shuren J. Litwack ED, et al. N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27. N Engl J Med. 2015. PMID: 26014594 No abstract available.

1. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Framework for regulatory oversight of laboratory developed tests (LDTs) — draft guidance. Silver Spring, MD: FDA; 2014. ( http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/...)
1. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. FDA notification and medical device reporting for laboratory developed tests (LDTs) — draft guidance. Silver Spring, MD: FDA; Oct 3, 2014. ( http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/...)
1. Department of Health and Human Services, Food and Drug Administration. Optimizing FDA’s regulatory oversight of next generation sequencing diagnostic tests — preliminary discussion paper. Silver Spring, MD: FDA; Dec 29, 2014. ( http://www.fda.gov/downloads/medicaldevices/newsevents/workshopsconferen...)
1. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Optimizing FDA’s regulatory oversight of next-generation sequencing diagnostic tests. Silver Spring, MD: FDA; Feb 20, 2015. ( http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferen...)
1. The White House Office of the Press Secretary. Fact sheet: President Obama’s Precision Medicine Initiative. 2015 Jan 30; ( https://www.whitehouse.gov/the-press-office/2015/01/30/fact-sheet-presid...)