COVID-19 is a perfect example of a novel disease for which there is an urgent need for both vaccines and therapies. To help reduce the application review timelines, the FDA issued guidance for Pre-IND meeting requests in May. We summarize the recommendations and provide advice from our regulatory affairs team.
Keeping a site functional, even in slow times, ensures it is ready as soon as there’s a need. Based on our experience with sites worldwide, we've identified the key areas on which sustainable sites proactively focus.