Vaccine Pathways to Market
Once the vaccine sponsor believes it has generated sufficient data to meet FDA’s safety and effectiveness requirements, the sponsor can submit a Biologics License Application (BLA) or request for an Emergency Use Authorization (EUA)(when appropriate) to FDA. This session will describe these procedures, as well as the rigorous process FDA uses to review the data in consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). We will also discuss other considerations such as the role of other government entities and post-approval pharmacovigilance. The illustration of COVID-19 vaccines in relation to this process will also be discussed.
- BLA Standard
- EUA Standard
- Role and Process of VRBPACVa
- Role of Other Government Entities
- Post-Approval Pharmacovigilance
Colleen M. Heisey, Partner, Jones Day
This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021.
COLLEEN M. HEISEY is a partner at the law firm of Jones Day, where her practice focuses on food and drug law with an emphasis on product promotion and advertising, compliance counseling, good manufacturing practice requirements, product recalls, FDA inspection, competitor issues, and enforcement actions. She has advised on issues surrounding the regulation of drug, biological, food, dietary supplement, medical device, and cosmetic products by the FDA, USDA, and other federal and state agencies.Get Access
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