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.
Other Products
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Breakthrough Therapy Designation
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IND Filing
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FDA Rare Pediatric Disease Designation
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Fast Track Designation
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FDA Meetings: INTERACT/Pre-IND Meeting, Type A, B, C and D Meetings
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FDA Orphan Drug Designation
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pluriStrainer Mini 5µm (Membrane)
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