Brooke Higgins

Brooke K. Higgins is a Supervisory Regulatory Specialist for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for reviewing both international and domestic drug CGMP cases and supporting regulatory and enforcement actions and provides training to FDA investigators and compliance officers within CDER and the Office of Inspections and Investigations (OII). While in OMQ, she also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, now OII , first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a MS in Food Science, focusing on food microbiology, and a BS in Biology from Virginia Tech.