Top 8 Things You Must Do For a Successful FDA Meeting

Author: Mukesh Kumar
1. Open and Collaborative Effort
Consider it an open and collaborative effort. You'll receive great insight, and will benefit from the resources they put into it, and will be able to receive great feedback which will guide your process and greatly enhance your chances of gaining first cycle approval.
2. Meetings with FDA
Remember that the FDA is required to grant your requests for meetings. They aren't doing you a favor. They also recommend you to take advantage of the meeting process.
3. Being Prepared
Be as prepared as possible, including having appropriate subject matter experts with you. Your scientific rationale should be defended and justified.
4. Focus on Topic
Stay focused on the discussion, you want to get answers to your questions, so stay on topic, and listen to their responses. Don't get sidetracked, and be prepared with notes, questions and discussion points.
5. Consider Suggestions Carefully
Don't commit at the meeting to new suggestions for studies, you want to consider them carefully and shouldn't be tied down to an on the spot decision.
6. Listen and ask follow-up Questions
Listen to what the responses are, ask follow-up questions, and pay attention to the subtext of what's being said.
7. Relevance
Remember that business logistics including financial or time constraints, or marketing concerns, have no relevancy. You should also avoid bringing lawyers to the meetings as well.
8. Specific Question and Answers
Finally, keep in mind that it's not necessary to have all the meetings in the book, and some could hurt more than they help. You want specific questions and answers, and to avoid speculative discussions or requests for data not within your comfort or technical need.

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