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The formal application to sell a drug: a New Drug Application for small molecules, a Biologics License Application for antibodies and cell therapies (US), or a Marketing Authorisation Application (EU). The PDUFA date is the deadline by which the FDA has promised a decision.
Applications run to hundreds of thousands of pages covering trials, manufacturing and labelling. Under the Prescription Drug User Fee Act the FDA commits to act within 10 months of filing acceptance (standard) or 6 months (priority review), plus a 60-day filing period, so 'PDUFA date' is watched by patients and investors alike. Real-Time Oncology Review and rolling submissions shorten the clock; Project Orbis coordinates review with other countries. Outcomes are approval, a complete response letter, or (rarely) withdrawal by the sponsor. Supplemental applications (sBLA/sNDA) add indications to existing drugs.
Shares ODAC (Oncologic Drugs Advisory Committee), Full (traditional, regular) approval, FDASIA 2012 and the origins of the expedited programmes, Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments.
Shares Project Orbis, Fast Track and RMAT designations, Breakthrough Therapy / Priority Review / Priority Voucher, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Complete response letter (CRL), Full (traditional, regular) approval, Trial lifecycle: from protocol to label, Pivotal (registrational) trial.
Shares Fast Track and RMAT designations, Breakthrough Therapy / Priority Review / Priority Voucher, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Project Orbis, Regulation (EC) No 726/2004: the EU centralised procedure, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Label, indication and label expansion, Fast Track and RMAT designations, Breakthrough Therapy / Priority Review / Priority Voucher.
Shares Fast Track and RMAT designations, Full (traditional, regular) approval, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares ODAC (Oncologic Drugs Advisory Committee), Full (traditional, regular) approval, Regulation (EC) No 726/2004: the EU centralised procedure.