Meeting Expectations: US FDA Communications Getting High Marks – Before COVID, At Least
FDA’s interactions with sponsors to support drug development activities are generally timely and effective – but industry still sees room for improvement in assuring ‘best practices’ are followed across all divisions.
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Will the US FDA agree to more structured communications amid its struggles with the existing meeting workload?
Waiting for paper letters to arrive can delay drug development, companies contend, but moving completely to e-communication may be difficult for the FDA.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.