A BLA is the request submitted to the US FDA for permission to introduce a biological product, such as a vaccine, antibody, cell or gene therapy, into interstate commerce. It is the biologics counterpart of a New Drug Application (NDA).
Free sandbox · No credit card · 21 CFR Part 11 aligned
Biologics License Application
noun · clinical research
A submission to FDA under the Public Health Service Act requesting a licence to market a biological product in the United States.
Related terms
In short
Explained
Small-molecule drugs are approved through NDAs under the Federal Food, Drug, and Cosmetic Act; most biological products are licensed through BLAs under the Public Health Service Act. Review happens in CBER (for vaccines, blood products, cell and gene therapies) or CDER (for many therapeutic proteins and antibodies).
The clinical section rests on the trials conducted under the IND. Their data must be traceable from the submitted datasets back through the eCRF to source, which is why data capture decisions made years earlier matter at submission. Capture exports include SAS transport (XPT) files, a data dictionary and an annotated CRF, and forms carry SDTM domain labels; SDTM datasets themselves are produced by your programmers. For accelerated programmes, see orphan, breakthrough and fast track designations.
An NDA is for drugs approved under the Food, Drug, and Cosmetic Act; a BLA is for biological products licensed under the Public Health Service Act.
The abbreviated licensure pathway for biosimilar and interchangeable biological products.
Under PDUFA goals, FDA aims to act within 10 months of the 60-day filing date for standard review, or 6 months for priority review.
FDA requires standardised study data, typically CDISC SDTM for tabulation and ADaM for analysis datasets.
Keep exploring
Traceable data with a complete audit trail. Free sandbox.