CDRH

At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products.

Two FDA officials last week highlighted the agency's ongoing efforts to personalize healthcare by improving internal expertise in pharmacogenetics, increasing its focus on regulatory science, and launching a new group to coordinate its drug and diagnostics divisions’ application reviews for Rx/Dx combination products.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.

NPR reports that government and private insurers are being slow to cover recently approved CAR-T cell therapies.

CNBC reports that there are thousands of genetic tests available for consumers to chose between.

In Nature this week: genomic analysis of ducks, whole-genome doubling among tumor samples, and more.