Office of Regulatory Affairs Undergoes Restructuring
The US Food and Drug Administration (Rockville, MD) is restructuring its Office of Regulatory Affairs (ORA) into two offices.
The US Food and Drug Administration (Rockville, MD, www.fda.gov)is restructuring its Office of Regulatory Affairs (ORA) into twooffices. The Office of Enforcement, headed by David Horowitz, will workto set ORA's priorities and develop policies and new methods. TheOffice of Regional Operations, headed by Diana Kolaitis, will takeresponsibility over operational aspects such as inspections andlaboratory work.
The reorganization is part of FDA's continuing efforts to increasecompliance and minimize risk. "Both operational and strategicleadership are essential to our success," said Margaret O'K. Glavin,associate commissioner for regulatory affairs, in a release. "We needto be clear on what we do, why we are doing it, how we are to do it,and where we are to do it."
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
