The US Food and Drug Administration only needs to approve 10 more novel agents by year-end to match its 2022 count of 45, a number that looks more than feasible given the 40 user fee goal dates for novel candidates coming up in the second half of 2023.
40+ Candidates Give US FDA Plenty Of Latitude While Growing 2023 Novel Approval Count From 2022
User fee goal dates in the second half of 2023 suggest cancer and breakthrough therapy approvals should recover from first-half dips and a resumption of inspections in China could revive COVID-delayed products.
