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词汇 Investigational New Drug
分类 英语词汇 英语翻译词典
释义

Investigational New Drug

英语百科

Investigational New Drug

Timeline comparing 'standard' drug approval procedure to several exceptional cases

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 marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the candidate drug usually enters a Phase 1 clinical trial. Regulations are primarily at 21 C.F.R.312.

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