Current FDA regulations and guidance define pathways that facilitate product development and licensure. New guidance is created and made available to industry and regulatory stakeholders to ensure the Agency is both responsive to emerging public health needs and to encourage the use of advancements in technology to improve product development. In response to the recent pandemic, guidance documents were created that defined accelerated product development mechanisms that allowed for enhanced interaction between the sponsor and the FDA review team, flexible submission schedules, and, in some case, shortened review timelines. These pathways were created to better support development of new products where a defined unmet medical need exists. In addition, in response to the recent pandemic, legislative initiatives directed the creation of two new guidance documents that will support future product development, review, and licensure. One on the use of platform technologies and the second on the use of advanced manufacturing technologies. This presentation will highlight the history of regulations related to vaccine development, review activities associated with vaccine development during an ongoing pandemic, and an introduction to the implementation of two new guidance documents
