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Concept information

Término preferido

investigational new drug application  

Definición

  • A “Notice of Claimed Investigational Exemption for a New Drug” (IND) is required under law to be submitted for any new chemical entity, biological, or antibiotic, before it is to be clinically evaluated in human subjects. Section 505 (a) of the federal Food, Drug, and Cosmetic Act states, “No person shall introduce into interstate commerce any new drug unless there is for that drug an approved New Drug Application or an effective IND.” There are three types of INDs: 1. [Source: Encyclopedia of Health Care Management; Investigational New Drug Application]

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URI

http://data.loterre.fr/ark:/67375/N9J-G190PJBF-X

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