Yifan Wang focuses her practice on FDA regulatory strategy, compliance, and product development across the lifecycle for life sciences and biotechnology clients. She brings nearly a decade of experience at FDA’s Center for Drug Evaluation and Research (CDER), where she served in multiple roles spanning policy, review, and inspection.
Yifan’s background in pharmaceutical manufacturing and health law informs her approach to supporting drug and biologics companies from early development through approval and post-marketing compliance.
Before joining Alston & Bird, Yifan was regulatory counsel in the Office of New Drugs (OND), where she advised on development and approval pathways for BLAs under the Biologics Price Competition and Innovation Act (BPCI Act). She helped to shape FDA policy and multiple guidance documents to streamline biosimilar development. Previously, Yifan was an accomplished reviewer in the Office of Pharmaceutical Quality (OPQ). She reviewed more than 120 NDAs and ANDAs and conducted pre-approval inspections around the globe.
She earned her J.D. from the University of Maryland, her Ph.D. in chemical and biochemical engineering from Rutgers University, and her B.S. in pharmaceutical engineering from Dalian University of Technology.
Yifan is a recognized expert in advanced pharmaceutical manufacturing technologies, including continuous manufacturing. She played a key role in FDA’s Emerging Technology Program. She received the FDA Outstanding Service Award for her contributions to making COVID-19 treatment available to patients.