The inside view of FDA's NDA and BLA review process — from someone who spent 24 years doing it.
Lisa Kammerman, Ph.D. — FDA statistical consultant and former FDA Master Statistical Reviewer, with 24 years reviewing NDA and BLA submissions.
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I consult with sponsors on trial design, statistical analysis plans, and FDA meetings — the same questions this newsletter works through, applied to your program.
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Kammerman Consulting, LLC