10 February 2017
The FDA recently released an online course to provide insights to drug sponsors on communicating with the FDA during drug development. The hour-long course, Best Practices for Communication Between FDA and IND Sponsors During Drug Development, is designed to describe the best practices and procedures for timely, transparent, and effective communications between IND sponsors and FDA at critical junctures in drug development.
After completing the course, IND sponsors are expected to have a greater understanding of FDA’s philosophy regarding timely interactive communication with IND sponsors, the scope of appropriate interactions between the FDA review team and IND sponsors, the appropriate types of advice for sponsors to seek from FDA in pursuing their drug development program, FDA’s general expectation for the timing of their response to IND sponsor inquiries, and the best practices and communication methods for facilitating interactions between the FDA review team and IND sponsors during drug development.
The course is divided into 7 lessons:
The course can be accessed here.
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