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 applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). This guidance describes:

  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between review teams and IND sponsors
  • The types of advice appropriate for IND sponsors to seek from FDA in pursuing their drug development programs
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between review teams and IND sponsors 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 with additional feedback from sponsors and review staff processes may evolve further. As additional best practices are identified or established, this guidance may be updated.

Posted on the FDA website on 28 December 2017