April is a Senior Advisor in the FDA/CDRH Total Product Lifecycle Program (TAP) since November 2023. Prior to her current role, April has served on the Obesity and Hepatobiliary Devices Team as the acting Assistant Director, Team Lead, Lead Reviewer, and chemistry consultant since 2014. In addition to supervisory, leadership, and medical device review responsibilities, April has promoted improvement in product manufacturing and quality through developing device specific FDA guidance documents, creating review tools to ensure consistency and quality in device review, and publishing external manuscripts on topics relevant to the FDA and industry on topics in the obesity and hepatobiliary device space. April has served as a Commissioner Fellowship Program (CFP) preceptor, mentor to new reviewers and advisors, and has developed and instructed Reviewer Certification Program courses.
Prior to joining CDRH in 2014, April was a Commissioner Fellow at FDA’s National Center for Toxicology Research (NCTR) and has served on the CFP Advisory Board. During her tenure at the NCTR, April did research to develop novel epigenetic approaches to safely assess the safety and carcinogenicity of FDA regulated products. Prior to joining the FDA, April was a post-doctoral scientist at the University of Pittsburgh, Children’s Hospital of Pittsburgh where she studied epigenetic regulation of congenital kidney disease in a mouse model. April also completed post-doctoral training at the Max Planck Institute for Biophysical Chemistry where she studied genetic and epigenetic regulation of neuromuscular disease. April has a PhD in Chemistry and BS in Physics from the University of Central Florida and an MBA from Florida Institute of Technology.
Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health
Wednesday, September 18, 2024
2:15 PM – 3:15 PM PDT