New Drug Application

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• New Drug Application — Regulation of therapeutic goods in the United States Prescription drugs Over the counter d …   Wikipedia

• New drug application — The 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. The goals of the NDA are to provide enough information to permit FDA …   Wikipedia

• New Drug Application — Die New Drug Application (NDA) stellt den Antrag auf Arzneimittelzulassung bei der US amerikanischen Behörde für Lebensmittel und Arzneimittelsicherheit (FDA) dar, welchen Arzneimittelhersteller stellen müssen, um eine Marktzulassung zu erhalten …   Deutsch Wikipedia

• Investigational new drug — The United States Food and Drug Administration s investigational new drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a …   Wikipedia

• Drug development — Drug research redirects here. For the journal, see Drug Research (journal). Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug… …   Wikipedia

• Drug Price Competition and Patent Term Restoration Act — Acronym Hatch Waxman amendments Citations Codification …   Wikipedia

• Drug Master File — or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document… …   Wikipedia

• Drug Efficacy Study Implementation — (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver Harris Drug Control Act) that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre… …   Wikipedia

• application — ap‧pli‧ca‧tion [ˌæplɪˈkeɪʆn] noun 1. [countable] a formal, usually written, request for something or for permission to do something: an application to do something • It hassubmitted an application to establish a distribution company. • The… …   Financial and business terms

• Drug design — Not to be confused with Designer drug. Drug design, also sometimes referred to as rational drug design or structure based drug design, is the inventive process of finding new medications based on the knowledge of the biological target.[1] The… …   Wikipedia

• Drug pipeline — A drug pipeline is the set of compounds (i.e. drugs in development) that a pharmaceutical company has under development at any given point in time. The development of drugs involves various phases that can broadly be grouped in 3 stages: pre… …   Wikipedia