Understanding the purpose of an IND
Opening an Investigational New Drug (IND) application dossier can allow a sponsor to take advantage of the FDA’s drug development expertise and ensure the development program will meet the agency’s expectations at the time of the marketing application.In a webinar replay, 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.
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