Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready?
In this webinar, 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
This webinar will help you better understand:
- Drug development overview
- Purpose of an IND
- When do you have enough data?
- Value of a pre-IND meeting