User Fee Goal Dates

Under PDUFA V, FDA is expected to act on applications for novel agents – new molecular and biologic entities – within 12 months of receipt under standard review and eight months under priority review, thanks to a two-month filing period added to the review goals for NMEs and NBEs. The review timeline remains 10 months for standard and six months for priority review for earlier applications and for non-novel submissions, like new formulations and delivery methods or new indications. Resubmissions with significant new data or analyses have a six-month goal. FDA may extend review timelines by three months for major amendments.