Brooke Higgins

Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance. In this role, Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry and preparing associated regulatory actions, and has served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, 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 drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.