It happens: You design your clinical studies around the FDA’s concerns, but it turns out you didn’t understand what the agency wanted. Maybe there were a different set of endpoints or patient sub-groups needed. You’re now stalled and have two time and money-consuming options: undertake costly and time-consuming additional studies or the appeal process. Using blinded case studies, this panel discusses how to avoid this situation. The focus is on sustained communications early in the development process, how to read the “tea leaves” of FDA communications, the most crucial milestones for communicating with the agency, and identifying factors within your organization that can keep you from really hearing what the FDA is saying.

Key Takeaways:

  • Explain how your company’s internal dynamics play a central role in whether or not it can “hear’ the FDA
  • Demonstrate the importance of creating a regulatory communications plan early in product development
  • Emphasize the high value of using outside experts to “pressure test” mission-critical FDA communications

Ability Level: All

Session ID: 2455

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