009: CMC Considerations For In-Human Studies with Drs. Edith Perez & Nathan Ihle
Business Of Biotech
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The Importance of an IND for Research
An IND is a program that has been set up by the FDA so that either researchers or pharmaceutical companies can apply to do essentially two things. Number one, evaluate a new agent or a combination of agents to be first used in humans. And number two, allow actually for that investigational agent to be transported from state to state before it's formally approved by the FDA. So critically important for research.
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