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Pharmaceutical Industry › Food and Drug Administration (FDA) › Decision-Making Process

McDermott Will & Emery

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

McDermott Will & Emery on

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more

Hogan Lovells

FDA Embraces Real-World Evidence in New Final Guidance

Hogan Lovells on

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

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