A BLA packages the manufacturing data, controls, and any supporting clinical evidence FDA needs to decide whether a biological product can be licensed for a stated use. It applies to products FDA regulates as biologic drugs under section 351, a different track from human cells, tissues, and cellular and tissue-based products (HCT/Ps) that meet the narrower criteria for the section 361 pathway and do not require premarket licensure.
FDA states that there are no FDA-approved exosome products. Exosome preparations are generally regulated as biologic drugs under section 351, and a product regulated under section 351 without a license is unlicensed for any clinical claim made about it. Purchase and clinical-use decisions for these products belong to the physician, working with the physician's own regulatory counsel.
Buyers should ask whether a specific product has an approved BLA and, if not, what its actual regulatory status is. A vendor should be able to describe its understanding of a product's classification and provide the underlying documentation. The purchase decision, and any related regulatory determination, remains the clinic's and its counsel's to make.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Knowing whether a product has, or needs, a BLA tells a buyer whether any claim about what the product does would require FDA licensure that does not exist.