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FDA's ONP Reorganization Challenges Industry To Prioritize OTCs

This article was originally published in The Tan Sheet

Executive Summary

FDA says OTC drug oversight remains important even as the Office of Nonprescription Products loses star billing within the Office of New Drugs, but the change could challenge firms to convince the agency to prioritize regulation of their products

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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.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

Room For Innovative Switches Could Lurk In Existing FDA Framework

When firms suggest submitting switch NDAs for “something that would be worth engaging on, we’re not going to tell you no,” says FDA nonprescription drug program chief Theresa Michele.

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