James Buening

Regulatory Health Project Manager, Division of Bioequivalence Process Management OB, OGD, CDER

James Buening is a Regulatory Health Project Manager in Division of Bioequivalence Process Management (OBPM), Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER) at FDA. Mr. Buening oversees assessment teams responsible for evaluating generic drug applications and other submissions under the GDUFA program. He leads multi-disciplinary coordination and planning to ensure timely approvals of life saving, high-quality generic medications. He began his career as a preclinical technician specializing in safety pharmacology. He is currently enrolled in the Public Health Science program at University of Maryland.”

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