Question: Don't forget the basics - - so begin by answering: What is your problem statement? Quality over quantity. How many recommendations do you have? How

Don't forget the basics--so begin by answering: What is your problem statement?
Quality over quantity.
How many recommendations do you have?
How clear are your next steps?
Are they actionable?
Are you clear on business and compliance costs?
Are you asking for any resources?
Do you provide more than one solution?
And are you clear on tradeoffs?
What do you expect the Leadership to take away from the meeting?
How does your work prepare the Company for the FDA meeting?
What do you expect to happen after the meeting?

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