FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice
The agency tells direct-to-consumer genetic testing company 23andMe in a strongly-worded warning letter that it should immediately stop marketing its Personal Genome Service until it can gain clearance. The firm says it will address the agency’s concerns.
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21st Century Cures Bill Could Create More Prescriptive Rx Approval Standards For FDA
Simplified and speedier drug approval process is focus for Reps. Upton and DeGette’s upcoming legislation – but getting there may mean more congressional micromanaging over FDA’s drug approval standards.
23andMe Has Accelerated The Consumer Genomics Debate
23andMe’s battle with FDA is another reminder that genomics is rapidly becoming incorporated not only into the clinic, but also into everyday life. It is forcing FDA and other agencies to take a stand on critical technical, legal, and ethical issues, which will influence the strategies of medical diagnostics and pharmaceutical companies as well as labs performing tests directly for the consumer.
510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014
CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.