CDER Safety Overhaul Planned As Review Process Modernization Continues

US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.

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An overhaul of safety reviews throughout the US FDA's Center for Drug Evaluation and Research is now on the docket along with modernization of the new drug assessment process.

A plan for the safety process changes is in development, CDER Director Janet Woodcock told the Pink Sheet in a...

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