Can We Talk? Rethinking FDA Communications With Drug Developers

PETER J. PITTS | December 25, 2019

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When it comes to 21st-century drug development, is the Food and Drug Administration (FDA) an accelerator or anchor for medical innovation? If the former, how can it do even better? If the latter, how big of a sea change is required? To address that question head on, the FDA held a November 7 hearing under the title, “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs.” The stated purpose of the open public meeting was to solicit specific, actionable policy suggestions for the review staff of the FDA’s Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for the assessment of safety and effectiveness of new drug products. Of interest are efforts that could be implemented in the near term and that cut across multiple therapeutic areas.

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