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OND Reorg Getting Warm Welcome From Review Divisions

Executive Summary

Division directors are embracing the reorganization of US FDA's drug review operations.

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OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

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Shared review memorandum under Office of New Drugs reorg will help eliminate last-minute surprises between disciplines and provide greater consistency between divisions.

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