Robert Seevers, Senior Advisor and Adjunct Board Member at Pearl IRB, 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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