Published in Medical Letter on the CDC and FDA, May 10th, 2006
The goal of this in-depth examination is greater internal consistency across the medical Centers at FDA for requiring, requesting, facilitating, and reviewing postmarketing study commitments.
Postmarketing study commitments, also called Phase 4 commitments, are studies conducted after FDA has approved a product for marketing that a sponsor is required, or has agreed, to conduct. These studies play a vital role in helping to complete the medical...
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