Speakers

Melissa Mannion is a Senior Regulatory Counsel in the Office of Generic Drug Policy (OGDP) at FDA.  In her current role, Melissa provides strategic leadership in the coordination, development, and implementation of new and improved policy solutions to support the approval of high quality generic drugs on the first lawful approvable date. She serves as a policy subject matter expert on a range of complex issues pertaining to generics, including bioequivalence, complex generic drugs and inactive ingredient sameness, pre-Hatch-Waxman ANDAs, exclusivities, and generic drug-device combination products. Prior to joining OGD, she also served as a Pharmacist and Regulatory Counsel in CDER’s Office of Compliance for several years. Melissa has almost 20 years of experience encompassing public health policy research, regulatory and legislative affairs, pharmaceutical purchasing and distribution, professional affairs, and retail pharmacy operations. Melissa earned her Bachelor’s degrees in Human Biology and Psychology from the University of California San Diego, and her PharmD and JD degrees from the University of Maryland Baltimore.