The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This 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
This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND.
Although this guidance describes FDA’s current best communication practices, it should be appreciated that a quality improvement process is dynamic and will continue to evolve over time with further feedback from sponsors and review staff. Thus, as additional best practices are identified or established, this guidance may be updated.