Drugs

FDA Issues 2 Drug Communication Guidances

David McFarland

— 2 min read
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FDA has published a final guidance and a draft guidance addressing communications between the agency and drug sponsors. The final guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, describes best practices and procedures for timely, transparent, and effective communication between IND sponsors and FDA at critical junctures in drug development, with the expectation that such communication may facilitate earlier availability of safe and effective drugs to the American public. It applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar product development, and describes: 

  •          the agency’s philosophy on 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 of the time of FDA response to IND sponsor inquiries;
  •          best practices and communication methods to facilitate interactions between review teams and IND sponsors during drug development; and
  •          expectations for appropriate methods, including the frequency, of such communications.

The document says it 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 says, “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.”

The draft guidance, Formal Meetings Between FDA and Sponsors or Applicants of PDUFA Products, has recommendations for industry on formal meetings between FDA and sponsors or applicants relating to development and review of drug or biological drug products regulated by CDER and CBER. It does not apply to ANDAs, applications for biosimilar products, or submissions for medical devices.

The guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. FDA says the general principles in the guidance may be extended to other nonapplication-related meetings with external constituents as much as possible.

Commenting on release of the guidance, FDA commissioner Scott Gottlieb says that “by engaging with product developers early, often before clinical research is underway or an application is submitted to the agency, the DA’s scientific experts can share important advice on the proper design of clinical trials and other aspects of the development and regulatory process. This early and more thorough engagement can help innovators meet FDA’s science-based requirements more effectively, meaning product developers will avoid costly delays that can unnecessarily impede access to beneficial new medicines.”

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