Dollars, Not New Authorities Needed To Advance Precision Medicine, FDA Chiefs Say
This article was originally published in The Gray Sheet
FDA and NIH officials appreciate a helping hand from Congress when it comes to funding for advancing precision medicine and advanced diagnostics, but they may be wary of taking too much direction from lawmakers on how to run the programs.
You may also be interested in...
The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.
Two promised draft guidances on FDA’s framework for regulating laboratory developed tests and notification and medical device reporting requirements for LDTs have been posted. The agency wants swift notification from labs for most available LDTs once a framework is finalized.
FDA said its new plan, which can’t be released as a formal draft guidance for another 60 days, would establish a more level playing field between test-kit makers and labs, while being flexible when there is not an FDA-approved alternative to an lab-developed test.