FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings

FDA and sponsors share the goal of productive and timely engagement during drug development. Effective interactions with FDA throughout development, from pre-IND to the clinical development phase, can minimize the risk of late-stage drug development failures, increase the probability that optimal safety and efficacy data are available in a timely manner and mitigate issues from arising, such as clinical holds. PDUFA VII provides significant resources to FDA for new formal meetings as the Agency noted limitations on face-to-face meetings and increased use of WRO was due to resource constraints. COVID has now changed the landscape for FDA/Sponsor meetings. FDA has acknowledged it is unclear when in person meetings will return and virtual meetings will remain a significant part of the FDA’s strategy post-pandemic to improve its communications with sponsors.