Did you know that you have a friend at the U.S. Food & Drug Association (FDA)? Someone who ensures that interactions with the regulators go well and that results are communicated to you promptly and efficiently. Someone who works very hard to coordinate reviews of your submissions and arrange requested meetings. I am talking about the Regulatory Project Manager (PM).
Recently, a client had a question that did not require a formal meeting with FDA but was important enough that the answer could change the development path. I identified the correct Project Manager within the appropriate division of FDA’s Center for Drug Evaluation and Research (CDER) and posed the question via email, explaining the reasons for asking and how providing an answer would smooth the review process for the eventual submission. And, not too many days later, we received a very helpful answer.
So, what does an FDA Project Manager do? When you request a meeting with FDA, the PM is the person with whom you interact. The PM will let you know if the Agency has agreed to meet with you and will set the date and time. The PM will follow up with you, sometimes persistently, about when the Briefing Document is due to FDA. If your meeting is face-to-face, the PM will greet you in the lobby of the Agency when you arrive and will run the meeting. And, the PM will provide the official FDA minutes once the meeting is finished.
However, coordinating and leading meetings are only part of the project manager’s responsibilities. Far more of their time is devoted to coordinating the review process for your submitted IND, NDA, or BLA. The PM is the face of the FDA for you during the review process. If something is missing from the submission, the PM will let you know. When the reviewers have questions, and they always have questions, the PM will communicate them to you along with the date by which you need to respond to keep the review process on target to meet FDA’s due date. If you are having trouble compiling a response to one or multiple questions before the deadline, it is the PM from whom you will request additional time.
Sometimes, unresolved issues will cause FDA to put your IND on “Hold”. If this occurs, the Project Manager will contact you to request a teleconference on day 29 or 30 of the review period. FDA management will communicate their reasoning for the Hold decision during this teleconference. Once your IND receives a “May Proceed” or your NDA or BLA is approved, it is most likely the PM who will inform you.
The details above provide a very high-level summary of an FDA Project Manager’s responsibilities. However, how does that make a PM your friend? In the past, it was sometimes considered acceptable to call an FDA reviewer directly to ask a question or discuss an issue. That is emphatically no longer the case. FDA strives to ensure that any answers provided by FDA reviewers have been thoroughly reviewed by management, and informal calls with reviewers would circumvent that. As a result, such informal calls are no longer permitted. Instead, it is the project manager who serves as the outward-facing communicator for FDA. So, if you have a question, you can contact the PM, as mentioned at the beginning of this blog, who will, in turn, run the question by the reviewer and management to provide you an official answer.
It is virtually certain that the project manager will pass any questions posed along to the review team; however, it is not guaranteed that they will agree to provide an answer. Framing your question appropriately will demonstrate to the project manager how providing an answer will make the review process easier for the FDA reviewer down the road. Also, if the PM knows you because you have built a relationship over time that is based on mutual respect and honesty, he or she is much more likely to help. At Pearl Pathways, we have worked with many FDA PMs over the years and have built just that kind of relationship with many of them, and we’d love to introduce you to your new friend at the FDA. Contact us today to begin a conversation.