The International Council on Harmonisation (ICH) released a new set of questions and answers (Q&As) for ECH E14 and ICH S7B in August 2020. On October 15 and 16, FDA hosted a webinar on the Q&A document. Dr. Robert Kleiman and Borje Darpo at ERT provide commentary on the revised ICH E14 and the S7B Q&As and what this may mean for drug developers.
