Darren has more than 20 years of experience with FDA regulated products, including drugs, biologicals, devices and combination products. He has directed and developed various pharmacovigilance and epidemiological assessments. These include over 200 regulatory and development projects requiring FAERS analyses, health claims database assessments, and adverse event/safety summaries. Many of these focused on product labeling adequacy. In addition to clinical protocol development and scientific writing, he has conducted hundreds of literature reviews and product assessments. His Ph.D. in Epidemiology allows Darren to be a key participant in the program development and teaching of pharmacovigilance, regulatory affairs, and product labeling at the College of Public Health, University of South Florida in Tampa.