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
Butylated hydroxyanisole. Butylated hydroxyanisole (BHA) is an antioxidant consisting of a mixture of two isomeric organic compounds, 2-tert-butyl-4-hydroxyanisole and 3-tert-butyl-4-hydroxyanisole. It is prepared from 4-methoxyphenol and isobutylene. It is a waxy solid used as a food additive with the E number E320.