{"entity":{"id":"full-approval","kind":"term","name":"Full (traditional, regular) approval","aka":["full approval","traditional approval","regular approval","standard approval","converted to full approval","conversion to regular approval","full FDA approval","received full approval","gained full approval","regular FDA approval"],"tldr":"The ordinary form of drug approval, granted when a trial has shown real clinical benefit such as longer survival, as opposed to an accelerated approval granted on an early stand-in measure and still awaiting confirmation.","summary":"Most oncology drugs first approved under accelerated approval later 'convert' to full approval when the confirmatory trial reads out positive (blinatumomab in 2018, tarlatamab in 2026 after DeLLphi-304); others go straight to full approval on a positive randomised phase 3. The distinction matters for payers and guidelines, and because a drug with accelerated approval may lose its indication if confirmation fails. Regulators may convert with a narrowed indication (ODAC concerns on dosing, as with belantamab's US label), and the phrase 'full approval' is often reported as a milestone in company and trial pages.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/New_Drug_Application","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/New_Drug_Application"}],"tags":[],"related":["accelerated-approval","confirmatory-trial","conditional-approval","approval-withdrawal","fdora-2022","fdca","bla-nda","japan-conditional-early-approval","cancer-drugs-fund"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/full-approval/","neighbours":{"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"bla-nda","kind":"term","name":"BLA / NDA / MAA (marketing applications) and PDUFA dates","route":"/terms/bla-nda/"},{"id":"cancer-drugs-fund","kind":"term","name":"Cancer Drugs Fund (England)","route":"/terms/cancer-drugs-fund/"},{"id":"conditional-approval","kind":"term","name":"Conditional marketing authorisation (EU)","route":"/terms/conditional-approval/"},{"id":"confirmatory-trial","kind":"term","name":"Confirmatory trial","route":"/terms/confirmatory-trial/"},{"id":"fdora-2022","kind":"term","name":"FDORA 2022 accelerated approval reforms","route":"/terms/fdora-2022/"},{"id":"fdca","kind":"term","name":"Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments","route":"/terms/fdca/"},{"id":"approval-withdrawal","kind":"term","name":"Indication withdrawal","route":"/terms/approval-withdrawal/"},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/"},{"id":"label-indication","kind":"term","name":"Label, indication and label expansion","route":"/terms/label-indication/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}]}}