Let’s say your company has a new drug with some exciting discovery and animal data, and you are planning for clinical development, including the Investigational New Drug (IND) application with the FDA. Do you have questions about the advisability and feasibility of a pre-IND meeting for your new drug? CDER SBIA created a website to help answer those questions. The site includes information on the benefits of a pre-IND meeting, how to request the meeting, and how to prepare and present your information at the meeting. At the end of the page is a list of the applicable rules and guidance. The web page is also a good way to get a rapid understanding of these meetings.

Text Copyright © 2019 Katrina Rogers