Matthew Dionne PharmD, MBA, BCPS U.S. FDA

CAPT Matthew R. Dionne, Pharm.D., MBA, BCPS is a Compliance Officer with the Food and Drug Administration's Center for Drug Evaluation and Research (CDER). With over 15 years of FDA experience, he ensures domestic and international pharmaceutical quality through comprehensive regulatory oversight and policy development. Dr. Dionne earned his Doctor of Pharmacy from the University of Rhode Island (2001) and MBA from Colorado State University (2012). He maintains Board Certification in Pharmacotherapy and holds Level III National Drug Investigator Certification. His career progression spans from FDA Investigator to senior Compliance Officer, with expertise in complex pharmaceutical manufacturing, sterile injectables, and regulatory enforcement. He has directed high-profile regulatory actions including injunctions, administrative detentions, warning letters, and regulatory meetings. His public health protection initiatives included COVID-19 vaccination sites, emergency response operations, and led many of the CDER OMQ excipient initiatives related to the 2022-2023 international diethylene glycol and ethylene glycol poisoning.