termsTerm

BLA / NDA / MAA (marketing applications) and PDUFA dates

aka BLA, NDA, MAA, biologics license application, new drug application, marketing authorisation application, marketing application, regulatory submission, filing accepted, submission accepted, regulatory review, PDUFA, PDUFA date, action date, target action date, goal date, rolling submission, standard review, 10-month review, 6-month review

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.

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Breakthrough Therapy / Priority Review / Priority Voucher Complete response letter (CRL)Fast Track and RMAT designations Label, indication and label expansion ODAC (Oncologic Drugs Advisory Committee)Pivotal (registrational) trial Project Orbis Real-Time Oncology Review (RTOR) and Assessment Aid Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)