Friday, July 2, 2021

New Spotlight on CDER Science on Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products

CDER's commitment to regulatory science involves the development of sound scientific methods and the performance of laboratory and clinical studies when needed to address reports of drug product contamination. Laboratory and clinical investigations, currently appearing in JAMA, showcase the mobilization of CDER research capabilities in the interest of protecting public health.

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