Sponsor/FDA Meetings (Pre-IND)

Prior to clinical studies, the sponsor needs evidence that the compound is biologically active, and both the sponsor and the FDA need data showing that the drug is reasonably safe for initial administration to humans. Under FDA requirements, the sponsor usually must first submit data showing that the drug is reasonably safe for use in initial, small-scale clinical studies.

Pre-clinical meetings are conducted with the appropriate review division that would review the drug marketing application and these meetings are typically requested by the sponsor of a drug. Meetings at such an early stage in the process are useful opportunities for open discussion about testing phases, data requirements, and any scientific issues that may need to be resolved prior to IND submission. At these meetings, the sponsor and FDA discuss and agree upon the design of the animal studies needed to initiate human testing. (see CFR 312.47, and CFR 312.82).