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
1 BHA is a mixture of the isomers 3- tert-butyl-4-hydroxyanisole and 2- tert-butyl-4-hydroxyanisole. 2  Also known as BOA, tert-butyl-4-hydroxyanisole, (1,1-dimethylethyl)-4-methoxyphenol, tert-butyl-4-methoxyphenol, antioxyne B, and under various trade names. 3  Molecular formula C 11 H 16 O 2.