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.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration

The US Food and Drug Administration splits its OTC drug office into two divisions five years after combining separate units into one and two years after the agency began preparing to reorganize the broader new products wing of its Center for Drugs Evaluation and Research.

CDER’s Office of New Drugs (OND) on 21 January announced changes to its organization including establishing the Office of Nonprescription...