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[1] The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use ...
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
A widely used artificial food dye could soon be outlawed. The U.S. Food and Drug Administration (FDA) is moving to ban an artificial food coloring called Red No. 3, also known as Erythrosine. The ...
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
General Motors said Tuesday it will retreat from the robotaxi business and stop funding its money-losing Cruise autonomous vehicle unit. Instead the Detroit automaker will focus on development of ...
The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
Realtor Scott Pratt, who works in Buford, Ga., north of Atlanta, said business was sluggish for much of the year, but he’s expecting to see more inventory hit his market this spring.