Originally slated to be released this summer, the guidance will detail the formal steps involved in qualifying biomarkers for FDA approval.
An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.
In Science this week: genetic target for urothelial bladder cancer treatment, and more.
At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.
Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.
Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.