Tuesday, December 4, 2018

Very Brief Blog: FDA Recognizes ClinGen Database for FDA Genetic Tests

Continuing its effort to smooth new pathways for FDA review of genetic tests of all types, FDA announced it has recognized ClinGen / Expert Curated Human Genetic Data as a database that may be referenced in submissions.

FDA press release (December 4, 2018) here.
For a Twitter message chain, see #fdarecognizesclingen here.

FDA cites its April 2018 guidance on use of databases in genetic test submissions.

Journals and Trade Journals 

Genomeweb covers the December 4 ClinGen story here, and cites back to a recent article in Genomeweb here about a special issue of the journal Human Mutation, here.   Volume 39, Issue 11, November 2018, had a series of open-access articles on ClinGen and Clin Var.