The FDA and genomic tests--getting regulation right.


The Food and Drug Administration (FDA) recently advanced two draft guidances1,2 proposing a regulatory framework for laboratory-developed tests, a category that includes many but not all genomic tests. The FDA convened a workshop in February 2015 to discuss the oversight of nextgeneration sequencing.3,4 President Barack Obama’s Precision Medicine Initiative… (More)
DOI: 10.1056/NEJMsr1501194


Cite this paper

@article{Evans2015TheFA, title={The FDA and genomic tests--getting regulation right.}, author={Barbara Evans and Wylie Burke and Gail P. Jarvik}, journal={The New England journal of medicine}, year={2015}, volume={372 23}, pages={2258-64} }