Brooke K. Higgins is the Pre-Approval Manager for Baltimore District in the Office of Regulatory Affairs. As Pre-Approval Manager, Ms. Higgins is responsible for conducting reviews of pending applications and providing CDER with recommendations for manufacturing facilities located within Virginia, Maryland, and West Virginia. Prior to becoming the Pre-Approval Manager in 2007, she worked as an Investigator with Baltimore District for five years, focusing mainly on drug manufacturing inspections. Ms. Higgins continues to lead drug manufacturing inspections, both domestically and internationally. She has been a member of the Pharmaceutical Inspectorate since 2009 and is a Level II drug certification auditor. Ms. Higgins received a Masters in Food Science and a B.S. in Biology from Virginia Tech.