The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products, and will discuss:
The intended audience for this event is: Regulatory Scientists assessing bioavailability studies as part of IND/NDA/BLA submissions; Research Coordinators overseeing in vivo studies in the context of IND/NDA/BLA submissions; Drug Development/New Drug industry scientists involved with bioavailability studies for support of a new/existing IND/NDA/BLA dossier; and foreign regulators.
Please visit the FDA’s In-Depth Look at BA Final Guidance Meeting website to register.