Investigational New Drug application

Investigational New Drug application
Медицина: (IND) Заявка на регистрацию нового экспериментального лекарственного средства (Investigational New Drug, IND)

Универсальный англо-русский словарь. . 2011.

Игры ⚽ Нужно сделать НИР?

Смотреть что такое "Investigational New Drug application" в других словарях:

  • 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

  • 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

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

  • Criticism of the Food and Drug Administration — Numerous governmental and non governmental organizations have criticized the U. S. Food and Drug Administration of either over or under regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health …   Wikipedia

  • Food and Drug Administration — FDA redirects here. For other uses, see FDA (disambiguation). Food and Drug Administration Agency overview Formed 1906 …   Wikipedia

  • Prescription Drug User Fee Act — The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided …   Wikipedia

  • U.S. Food and Drug Administration — Infobox Government agency agency name = Food and Drug Administration parent agency = logo width = 200px logo caption = FDA Logo formed = 1906 [cite web|url=http://www.fda.gov/centennial/|title=FDA Centennial 1906 2006|accessdate=2008 09… …   Wikipedia


Поделиться ссылкой на выделенное

Прямая ссылка:
Нажмите правой клавишей мыши и выберите «Копировать ссылку»