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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Division directors are embracing the reorganization of US FDA's drug review operations.
OND will grow to eight offices and 27 clinical divisions, which is slightly different than an early proposal.
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.