The purpose of the proceeding is to gather and distribute the decedent's assets. Understanding the terminology used in probate aids in reviewing probate file documents and determining the disposition of the taxpayer's assets. Common terms used in probate include: Testate-person who died testate had a will.he purpose of the proceeding is to gather and distribute the decedent's assets. Understanding the terminology used in probate aids in reviewing probate file documents and determining the disposition of the taxpayer's assets. Common terms used in probate include: Testate-person who died testate had a will.
The Orphan Drug Act 1983 (P.L. 97-414) as it amended the Federal Food, Drug and Cosmetic Act (FFDCA), and subsequent amendments, have shaped the US Orphan Drug Program. Under the FFDCA, the developer of an orphan drug product is guaranteed seven years of market exclusivity after FDA approval of the product.Drugs, biologics, medical devices and medical foods (mainly parenteral nutrition and nutraceuticals) can be given âorphanâ status.nder the FFDCA, the developer of an orphan drug product is guaranteed seven years of market exclusivity after FDA approval of the product. Drugs, biologics, medical devices and medical foods (mainly parenteral nutrition and nutraceuticals) can be given âorphanâ status.
This status is referred to as orphan designation (or sometimes âorphan statusâ). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDAâs implementing regulations at 21 CFR Part 316. sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit.