The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point. Stem...
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for...
Direct-to-consumer (DTC) tests, such as those marketed by 23andMe, are changing the classic paradigm of health professionals ordering and interpreting genetic testing for a patient. In this article, we provide an overview of the DTC landscape and the regulatory pathways. Not...