The value of a pre-IND meeting
We encourage the sponsors we work with to view FDA as a valuable development partner. In our experience, they have been very interested in engaging with sponsors to encourage the development of new drugs in a safe, effective, and efficient manner. FDA reviewers have a tremendous amount of experience, and while engaging the Agency effectively takes some skill, it is well worth the investment.Solve the Mystery - Learn How to Know if You Are Ready to Submit your IND to FDA
Veristat experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND. Hear from regulatory experts responsible for dozens of IND submissions who cover considerations such as selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research and more. The direction provided will help you determine whether you are ready to submit your IND and take the next step in the development of your product.
View the webinar replay to help you better understand:
- Drug development overview
- Purpose of an IND
- When do you have enough data?
- Value of a pre-IND meeting
Kevin Hennegan is a senior regulatory strategist at Veristat.