Deeona Gaskin

Practice Areas

DEEONA GASKIN served as Associate Chief Counsel at the U.S. Food and Drug Administration (FDA) and is now a partner in Sidley’s Food, Drug and Medical Device group. She provides strategic counseling to clients related to artificial intelligence and machine learning (AI/ML), chemistry, manufacturing, and controls (CMC), good clinical practice (GCP), current Good Manufacturing Practice (cGMP), Quality System Regulation (QSR), data integrity, product recalls, and adverse event reporting and pharmacovigilance. She also represents companies in False Claims Act enforcement actions and investigations.

Deeona has also provided training to FDA staff regarding inspections. While she was at the FDA as Associate Chief Counsel, she worked in conjunction with the Department of Justice (DOJ) to bring enforcement actions (including injunctions and seizures) involving drugs, medical devices, foods and dietary supplements, and personally negotiated many consent decrees. She also helped to defend the agency against lawsuits involving citizen petitions, import alerts and the Hatch-Waxman Amendments. During her time at the FDA, she received numerous awards, including the Department of Health and Human Services’ Office of the General Counsel Outstanding Newcomer Award.