Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-861

• A summary of information submitted as part of the application.
• Information on the applicant submitting the biologics license application.
• A preclinical data section.
• A clinical data section that includes safety and efficacy data on the product.
• Draft labeling of the product to be licensed.
• Information on the manufacturing, chemistry, and controls of the product.
• A data summary of validation of important processes and assays involved in the manufacture of the product.
• A description of the facility where the product is manufactured.
• Case report form tabulations on the manufacturer’s clinical experience with the product.
• Case report forms and serious event narratives.
• An index.

This is what we submit for a BLA

Safety efficacy and manufacturing ticked off.

if it's accepted it won't take long


Reg