Robert Seevers, Senior Advisor at Pearl Pathways, has been invited to deliver a lecture at Purdue University this Friday, February 16. Seevers will speak to an MS-level drug discovery class that aims to teach students how to apply and navigate current FDA regulations to deliver a drug, device, or diagnostic to market.
Seevers’ lecture topics will include:
- what constitutes an Investigational New Drug (IND) and a New Drug Application NDA
- a discussion of what the IND and NDA means to the U.S. Food and Drug Administration (FDA)
- the IND and NDA review processes
- the “right” and “wrong” ways to ask FDA questions
- the power of FDA guidances
- the importance of understanding the risk/benefit ratio of a particular drug for a specific indication
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