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).