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News and Press: MichBio News

biolink Regulatory Column - June 2014

Wednesday, June 18, 2014   (1 Comments)
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Having Productive Meetings with FDA, Part 2

Ross Lobell, Vice President, Regulatory Affairs, RegSource Consulting

In April I wrote of important considerations when requesting a meeting with FDA. This month, I will present pointers to make your FDA meeting as productive and successful as possible.

Once all meeting documents are completed, preparation for the meeting itself can begin. This starts with deciding attendees and what their roles will be. If consultants are involved, it is important to make sure that they will meet the needs of the meeting without being a distraction. This means that they can be communicative yet diplomatic, make good scientific contributions, and have relevant experience (including prior FDA meetings).

The next three items on the “to do” list are Practice! Practice! Practice!  The group should have a strong leader who will develop a team preparation plan, keep the meeting focused and on track to achieve the most important outcomes, and direct questions from FDA to the appropriate sponsor person. Since your team will have rehearsed a myriad of questions, most will be easy to direct and answer. FDA has a unique perspective, so rehearsing in front of a “mock” FDA group as the meeting nears, can help the team effectively respond to a variety of potential questions.

At the meeting itself, prioritize your time on the most important agenda items. This is an important role for the leader and can be tricky if mid-meeting adjustments are necessary. Ensure your team communicates clearly and concisely, and remains professional. Make sure that the team listens closely to what is being recommended, and ensure that the outcomes are summarized at the end of the meeting and properly minute the meeting. 

Lastly, remember that FDA is happy to have a scientific discussion, but is put off by commercial considerations. Their goal is always safety and efficacy.


Norm Howe, Validation & Compliance Institute, LLC says...
Posted Wednesday, June 18, 2014
Well said regarding "FDA is happy to have a scientific discussion", Ross. Gaining a clear understanding of what FDA thinks is critical in your technology can prevent so many detours as the project progresses. It continues throughout the product lifecycle. I can't count the number of companies I seen get bogged down in Process Validation because they didn't know their own technology.

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