FDA Will Launch Pilot To Speed Review Of Drugs For Unmet Medical Needs

By Beth Wang / August 24, 2021 at 12:56 PM
FDA will launch a pilot program in fiscal 2023 to expedite reviews and approvals for novel uses of existing therapies that meet an unmet medical need, the agency says in its fiscal 2023-2027 prescription drug user fee commitment letter published Monday (Aug. 23). Through the Split Real-Time Application Review (STAR) pilot program, FDA hopes to expedite patient access to novel uses of existing therapies by starting reviews earlier than would otherwise occur, which will also allow for earlier approval of...

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