BioCentury
ARTICLE | Regulation

Getting to certain

FDA solicits solutions to solve for uncertainty in risk-benefit framework

May 19, 2014 7:00 AM UTC

As FDA moves closer to installing a new risk-benefit framework for drug reviews, it still is grappling with how to address uncertainties in the process.

Last week, the agency and the Institute of Medicine concluded a workshop to discuss the dilemma, which didn't identify entirely new methods, but did yield recommendations for adapting known approaches to more formally quantify areas where knowledge is missing or of unknown validity...