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.
In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive.n an effort to reduce the burden on manufacturers applying for orphan drug status, the FDA and EMA agreed in late 2007 to utilize a common application process for both agencies.