People who have had their adrenal glands removed will have to take a glucocorticoid (like cortisone) and mineralocorticoid fludrocortisone (brand-name Florinef) for the rest of their life. There may be a concern that the pituitary tumor will enlarge, so MRI imaging of the pituitary gland may be done after this surgery.
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 â 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: Applicant information
SPLA stands for Service Provider Licensing Agreement (SPLA). The key difference between a SPLA license and a license that comes with a boxed product (similar to something you would buy at a retail store) is the person who uses the software. The software you buy at a retail store can only be used by the person who purchased it.