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.

A new study finds that a placental protein linked with preeclampsia can be targeted by RNA silencing, according to the New Scientist.

A settlement is expected in a Duke University lawsuit hinging on using falsified data to win grants, Retraction Watch and Science report.

In PNAS this week: approach for analyzing the expression of endogenous retroviruses, circular RNAs that influence host-virus interactions, and more.

A phylogenetic analysis finds that the rare hemimastigotes form their own supra-kingdom, CBC reports.