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IND Filing

Category: Biotech Service

Exhibitor: ONLY ORPHANS COTE LLC

Booth No: L724

Characteristic

The IND filing is a submission made to the FDA by a pharmaceutical company or sponsor before conducting clinical trials with an investigational drug in human subjects. The IND application is a comprehensive document that contains all relevant preclinical data, information on the drug's manufacturing, and a detailed clinical trial protocol. Once the IND is in effect, the sponsor can proceed with conducting clinical trials.

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