FDA releases draft guidance on IND sponsor communication best practices

December 28, 2015

FDA Alert

Author(s): Lynn Gordon

Copyright 2015, American Health Lawyers Association, Washington, DC. Reprint permission granted.

Draft guidance from the U.S. Food and Drug Administration (FDA) brings sponsors one step closer to final best practices guidance on investigational new drug application (IND) sponsor communications. With the goal of bringing new drugs to the market on a more timely and efficient basis, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of FDA published the draft Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff, on December 9 (FDA Draft Guidance). [1]

The FDA Draft Guidance is based on CDER and CBER review of numerous suggestions from both FDA review staff and industry representatives responding to a 2014 notice published in the Federal Register, as well as direct input to CDER’s communication team members.[2] While such guidance, once finalized, will not constitute any binding regulations, nor will it establish any rights for IND sponsors, it should inform communications between such sponsors and FDA as drugs and biologics are under development. Therefore, it is important that IND sponsors review and provide comments on the FDA Draft Guidance, and review such guidance against current practices, in order to further shape it prior to final publication and to better prepare for any changes to their respective current communications policy and procedure.

Per the U.S. Department of Health and Human Services announcement on the best practices guidance, “The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug (IND) sponsors and FDA in critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.” [3]

The introduction to the FDA Draft Guidance describes the following as its basic components:

  • 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; and
  • Expectations for appropriate methods, including the frequency, of such communications. [4]

This guidance provides thoughtful pointers on all of these components, from handling challenges in obtaining timely feedback from the review division regulatory project manager, to meeting requests, pre-meeting preparation, and meeting conduct. It also provides a roadmap to available resources that may already address specific scientific and regulatory questions, in order to facilitate sponsor use of self-service tools and to better focus communications on new issues and questions that arise during the process: “Sponsor use of these tools allows for more effective utilization of FDA resources in providing advice on scientific and regulatory issues that fall outside of established guidance, policy, and procedures.” [5]

CDER and CBER representatives are seeking comments on this draft guidance by February 8, 2016. Electronic submissions can be submitted here. Paper submissions should be directed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments will be posted and any confidential information should be submitted in writing and submitted, marked, and identified as confidential, as further instructed in the link noted above.

  1. See Best Practices for Communication Between IND Sponsors and FDA During Drug Development; Guidance for Industry and Review Staff, December 9, 2015. Available here. (last visited December 21, 2015). [Back to reference]
  2. 79 Fed. Reg. 64397 (October 29, 2014). [Back to reference]
  3. See Best Practices for Communication Between Investigational New Drug Sponsors and Food and Drug Administration During Drug Development; Draft Guidance for Industry and Review Staff; December 9, 2015. Available here. (last visited December 21, 2015). [Back to reference]
  4. See Endnote 1 supra at pg. 1. [Back to reference]
  5. Id. at 20. [Back to reference]

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