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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
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 ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Here’s what you need to know: In rushing out their assessment of Russia’s interference in the 2016 election, Obama-administration officials chose not to include the risible Steele-dossier ...
The Global Dossier is an online public service launched in June 2014 by the five "IP5" offices, i.e. the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), China's National Intellectual Property Administration (CNIPA) and the US Patent and Trademark Office (USPTO), to offer an integrated access to the respective "file wrappers", free of ...
Interfolio was created to streamline the college application process for academic jobs by providing an online portfolio and application system. Principal Interfolio services includes Dossier, a service for collecting, curating, and delivering academic materials to scholarly opportunities. [ 12 ]
A dossier is a collection of papers or other sources, containing detailed information about a particular person or subject. Dossier can also refer to: Arts, entertainment, and media
In the information sciences, an application profile consists of a set of metadata elements, policies, and guidelines defined for a particular application. [1]The elements may come from one or more element sets, thus allowing a given application to meet its functional requirements by using metadata from several element sets - including locally defined sets.