Form 483 Field Guide: FDA Follow-Up for Life Sciences Manufacturers

SONIA W. NATH is a partner in the litigation and healthcare, life science, and FDA regulatory groups at Cooley LLP. Before joining Cooley, Sonia served for nearly a dozen years in the FDA’s Office of the Chief Counsel (OCC), handling litigation matters for the agency across the gamut of FDA-regulated products, including pharmaceuticals, medical devices, conventional foods, dietary supplements, OTC drugs, animal drugs, tobacco, and biologics. Sonia handled civil enforcement actions and defensive matters for her first eight years in OCC. During her last four years in the office, she also handled criminal prosecutions involving a wide variety of FDA-regulated products in her appointed role as Special Assistant United States Attorney (SAUSA) with the U.S. Attorney’s Office in the Central District of California. In 2018, Sonia received the Award of Merit, the agency’s highest award, for her dedication to the agency’s mission through enforcement activities.