AM23-SN-02-O: Navigating the FDA Licensure Pathway (Enduring)

This session will review the steps required when applying to the Food and Drug Administration (FDA) for an original Biologics License Application (BLA) to manufacture, modify, market and distribute blood components and biologics in interstate commerce. An overview of the initial submission requirements will be provided. Changes to an approved application which require supplemental reporting including labeling, production processes, quality control, equipment and facilities will be outlined. The change reporting parameters, requisite materials and implementation time frames for Changes being Effected (CBE and CBE30) or Prior Approval Supplement (PAS) will be discussed. The applicability and content of a comparability protocol for submitting an alternate procedure will be described along with the implementation timeframes. The Annual Reporting (AR) obligations to FDA for licensed facilities will be defined. The pathways available to submit these various applications and supplements will be examined along with a demonstration of the sign-on and navigation of the FDA electronic submission process. Lessons learned through these various application processes will be shared to help streamline the learning curve for new submitters. If you’re just starting down the FDA registration and licensing pathway or a seasoned navigator hoping to avoid inadvertently taking the wrong fork in the road, this session is for you!