1. The sponsor submits a BLA for the biological product, including the data and manufacturing information needed for FDA review.
2. The FDA reviews the application and may grant accelerated approval if the regulatory criteria are met, including evidence of an effect on a surrogate endpoint reasonably likely to predict clinical benefit.
3. Confirmatory studies are required to verify the anticipated clinical benefit, and the FDA can require certain studies to be underway before approval or within a specified period afterward.
Quote:BLA has NOTHING to do with granting an AA