Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open-Sourced Tool

Greg joins Jacqueline Corrigan-Curay, Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, and Robert (Mac) Gordon, Director, Biostatistics, Johnson & Johnosn Innovative Medicines, to present and introduce how the program safety analysis plan (PSAP) allows reviewers an effective way to perform annual aggregate safety review across a compound. Utilizing an interactive ‘real time’ application gives the ability to continuously review the safety profile. An evolution of the PSAP, the Aggregate Safety Assessment Plan (ASAP) will be introduced and discussed.