Monday, March 25, 2013
Industry, patient and investor
stakeholders say FDA's new benefit-risk framework could become a
powerful aid to communication and discussions with the agency. But so far the
agency has no plans to share the documentation created by the scheme with
sponsors or the public, except after a product approval and probably in
advisory committee meetings.
Thus the framework's most
near-term effect will be within FDA, where the new tool will assist the agency
with its most difficult decisions - including the resolution of internal
disagreements about the balance between benefit and risk.