The draft guidance describes:
- FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
- The scope of appropriate interactions between the review team and the sponsor
- The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program
- General expectations for the timing of FDA response to IND sponsor inquiries
- Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development
- Expectations for appropriate methods, including the frequency, of such communications
FDA’s recommendations particularly relevant to RPI’s areas of expertise include:
- Because sponsors are ultimately responsible for managing the overall development program for their proposed drug, sponsors should closely monitor for advances in the field and/or changes in FDA guidance, and inquire if those changes may necessitate changes in prior FDA recommendations for their development program.
- Sponsors should only submit milestone meeting requests when drug development has progressed to the point where a full discussion of issues germane to that development stage is possible. Premature meeting requests are often denied by FDA.
- Sponsors should submit a limited number of clearly worded and targeted questions that directly address concerns about the drug and development program. The number of questions in a meeting package should not exceed what can be reasonably discussed within the duration of allotted meeting time.
- Sponsors should provide sufficient data to support the questions being asked. If the meeting package is determined to be inadequate or too voluminous, the meeting may be rescheduled.
- Sponsors’ meeting packages should be well-organized and indexed to enhance the readability of the background information both before and during the meeting.
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