Dr. Brevig started her FDA career in CDRH’s Division of Chemistry and Toxicology Devices in the Office of In-Vitro Diagnostics and Radiological Health working on pre-market review and post-market compliance for diagnostic devices. The day-to-day activity included the review of 510(k)s, PMAs, IDEs, Pre-Submissions, 483s, Warning Letters, It Has Come to Our Attention Letters, Recalls, MDRs, and Import Alerts.
She moved from the medical device space to biologics with CBER’s Division of Manufacturing and Product Quality in the Office of Compliance and Biologics Quality (OCBQ). There, she worked on manufacturing reviews for BLA supplements and EUAs. She also conducted onsite Pre-Approval Inspections and site visits and reviewed records in advance and in lieu of an inspection. Dr. Brevig also detailed with CBER’s Division of Case Management in OCBQ, reviewing 483s, Warning Letters, It Has Come to Our Attention Letters, Recalls, BPDRs, and Import Alerts.
Prior to the FDA, Dr. Brevig was a research analyst for the Center for Naval Analyses where she evaluated implementation of healthcare related programs and policies, and provided recommendations on funding science and technology programs for the Navy and Marine Corps.
Dr. Brevig earned a Ph.D. in Pharmacology from the University of Michigan, Ann Arbor.
B.S., Biology, University of California, Irvine
Ph.D., Pharmacology, University of Michigan, Ann Arbor