CDER Wants YOU to Tell It How to Improve the Integrated Review; We Have a Few Ideas of Our Own
FDA Law Blog
SEPTEMBER 24, 2024
By Deborah L. Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. The NDRP focused on six strategic objectives one of which was the implementation of the Integrated Assessment which per CDER was designed to “critically, collaboratively, and consistently assess whether inf
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