December 29, 2017
Authored and Edited by Christina Ji-Hye Yang; Shana K. Cyr, Ph.D.
On December 28, 2017, FDA released nonbinding guidance on “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” FDA intends the guidance to promote timely, transparent, and effective communications between IND sponsors and FDA at critical junctures in drug development, including biosimilar biological product development.
The guidance addresses (1) FDA’s philosophy regarding communications with sponsors, (2) the scope of interactions between sponsors and FDA, (3) the types of advice that are appropriate for sponsors to seek, (4) general expectations for timing of communications; and (5) best practices and communication methods.
First, the guidance indicates that, with respect to INDs, sponsors’ primary responsibilities are managing the development of their drugs, determining the nature and timing of their IND submissions, soliciting input and guidance from FDA, and providing well-organized and complete IND submissions to FDA. FDA’s primary responsibilities are to ensure the safety and rights of subjects, to help ensure that the drug’s effectiveness and safety are adequately addressed, to enforce requirements related to good clinical practice and human subject protections, to review IND submissions and take regulatory actions, to provide advice and feedback to sponsors, and to promote the advancement of regulatory science.
Second, the guidance emphasizes that IND sponsors’ primary point of contact at FDA is the review division regulatory project manager (RPM), though sponsors may contact others at FDA in limited circumstances. Sponsors should not communicate directly with reviewers assigned to their INDs except in the rare instance where they have supervisory approval. Sponsors and FDA RPMs should establish a mutually agreeable communication strategy that includes preferred method(s) of communication, frequency of communications, and expectations for the timing of responses to inquiries. A formal communication plan may also be established.
Third, the guidance identifies topics for which sponsors may solicit FDA’s feedback, including regulatory; clinical/statistical; safety; clinical pharmacology and pharmacokinetics; nonclinical pharmacology, pharmacokinetics, and toxicology; product quality; and pediatrics. Before soliciting FDA’s feedback, sponsors are strongly encouraged to consult other available resources, such as those identified in the guidance.
Fourth, the guidance notes that FDA prioritizes responses to safety-related inquiries first and may require additional time to respond to questions that are complex or involve combination products. The guidance recommends that sponsors raise complex questions in requests for formal meetings or in formal submissions. Sponsors who encounter delays by FDA should contact the appropriate individual at FDA in the stepwise manner set forth in the guidance.
Fifth, the guidance indicates that as a best practice, FDA will use words that reflect statutory or regulatory requirements and words that effectively communicate advice. FDA recommends meetings between FDA and a sponsor at critical junctures in drug development, and provides meeting-related best practices. The guidance also provides best practices on other topics, such as submissions from sponsors, including adherence to the required timelines and fully describing areas of concern in their submissions; email, general telephone calls, and faxes between FDA and sponsors; and resources for sponsors, including FDA guidances, policies and procedures, and web pages with basic information for industry.
Readers are encouraged to read the guidance, available on FDA’s website.
Food and Drug Administration (FDA), drugs, FDA Guidance, Investigational New Drug Application (INDA)
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