Getting to certain
FDA solicits solutions to solve for uncertainty in risk-benefit framework
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.
The workshop was part of FDA's PDUFA V commitment to create and implement a benefit-risk framework. In March 2013, FDA disclosed the components of the framework, which seeks to standardize the way reviewers consider benefit