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.
Information on applications for orphan drug status can be found in the Applications for orphan drug designation. The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered medicines.Drugs designated as orphan drugs by the TGA are shown in the table below.esignated orphan drugs are eligible for a waiver of their application and evaluation fees, but only if designation is received prior to submitting an application to register an orphan drug on the Australian Register of Therapeutic Goods (ARTG) .