Monday, May 6, 2013
While the first meeting under FDA's
Patient-Focused Drug Development initiative focused only on one disease -
chronic fatigue syndrome - it did make clear the challenges the agency faces in
making use of anecdotal information to make regulatory decisions.
Under PDUFA V, FDA committed to
hold public meetings focused on 20 diseases to solicit patient perspectives
that can inform the agency's benefit-risk assessment for drug and biologics
reviews (see BioCentury, March 25).