On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely, transparent, and effective communication between IND Sponsors and the FDA.
The draft guidance includes the following best practices for FDA communication with IND Sponsors:
In the draft guidance, the FDA states that “effective and timely communication between FDA and Sponsors promotes understanding of mutual goals and is invaluable to the drug development process. Central to this is the ability to communicate clearly, both orally and in writing, inside and outside the formal meeting format.” As such, the Agency will abide by the following best practices when communicating with Sponsors of IND applications:
FDA meetings are essential for both Sponsors and the Agency. They help resolve questions and issues that may come up during drug development and allow Sponsors to confirm that they are on the same page as the FDA. In order for Sponsors to achieve efficient drug development, it is absolutely critical that they learn FDA’s views on all applicable requirements prior to submitting an application.
The draft guidance states that these meetings occur at critical points in drug development, and include:
The draft guidance also provides a comprehensive list of best practices for meeting-related communication between Sponsors and the FDA. A full list of meeting-related best practices is available here.
In addition to meeting-related best practices, the draft guidance provides Sponsors with additional recommendations regarding:
In addition to best practices, a number of FDA recommendations for IND-related communications are provided in the draft guidance.
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:
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:
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).
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.
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