Last month, FDA published a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance was published with the intention of promoting timely, transparent, and effective communication between IND sponsors and the Agency.
In addition to best practices, a number of FDA recommendations for IND-related communications are provided in the draft guidance.
Roles & Responsibilities
The document states that, in ideal situations, the FDA will work collaboratively with sponsors throughout the entire drug development process. In addition, both parties have “distinct roles and primary areas of responsibility,” which are defined as follows:
Scope of Interactions
CDER review division's regulatory project managers (RPM) have comprehensive knowledge of his or her applicable drugs and its regulatory history. Therefore, the document designates the RPM as the primary point of contact for IND sponsors to communicate with the FDA during the drug development process. In addition, “the RPM is also the primary contact for facilitating the timely resolution of technical, scientific, and regulatory questions, conflicts, or communication challenges between the sponsor and the review team.”
The guidance also says the Agency understands that, at certain times during drug development it may be appropriate for sponsors to contact other FDA project managers. These include:
Types of Advice
Throughout drug development, sponsors request regulatory and scientific feedback from the FDA on a regular basis. The FDA provides sponsors with recommendations regarding the types of advice that are appropriate for sponsors to ask for, including:
FDA reminds sponsors that the Agency’s resources are limited. As such, it advises sponsors to seek answers to their questions through the various resources available prior to contacting the FDA. (More information on the available resources in section VII.I., Resources for Sponsors, of the draft guidance, here).
Expectations for Timing
The FDA offers details on the timeline of communication, providing the following information concerning the Agency’s response to the questions incorporated in meeting packages and submissions:
The draft guidance also says, “all other sponsor inquiries, received via telephone, email, or in a submission (i.e., a submission without a review timeline described in a MAPP), that include specific questions for which sponsors are seeking FDA feedback, FDA project managers will strive to acknowledge such communications via telephone or email within three business days of receipt by the FDA project manager. FDA’s acknowledgment will:
The Agency states that, although it strives to adhere to all established/estimated timelines, it is not always possible. If sponsors experience delays in obtaining the FDA’s responses, the document provides a recommended approach, which should be taken sequentially.
For additional details on FDA recommendations for IND-related communication, view the draft guidance here.
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