Search results
Results From The WOW.Com Content Network
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 ...
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
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.
A dossier is a collection of papers or other sources, containing detailed information about a particular person or subject. Dossier can also refer to:
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 United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
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 ]