Brooke K. Higgins, MS CDER/OMQ/US FDA

Brooke K. Higgins is an Acting Branch Chief and Senior Policy Advisor for the Division of Drug Quality I, Office of Manufacturing Quality, with in CDER’s Office of Compliance. In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also 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, Ms. Higgins 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.