Frame work

A little over four years into its implementation, FDA’s structured benefit-risk framework appears to be meeting its objectives of creating transparency into its approval decisions.

The agency began to incorporate the framework templates into its reviews of drugs and biologics in 2013. The standardized approach is intended to focus reviews more explicitly on the trade-offs between benefits and risks, increase transparency around the factors driving decisions, make reviews of similar products more consistent, and explain and resolve disagreements within the agency...