Karena Cooper JD, MSW

Karena Cooper serves as Regulatory Counsel within the Food and Drug Administration's Center for Drug Evaluation and Research Office of Compliance. Karena is responsible for researching a broad range of issues concerning the Food, Drug and Cosmetic Act, Prescription Drug User Fee Act and related statutes enforced by FDA, co-located with CDER Division of Scientific Investigations. She also performs initial review of enforcement actions initiated by CDER Division of Scientific Investigation, including Warning and NIDPOE letters. Karena earned her law degree from the University of Maryland School of Law in Baltimore.


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