FDA Publishes More Than 200 Complete Response Letters
PharmaTech
JULY 11, 2025
A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Moreover, when the FDA recommended a new clinical trial, that fact was left out of sponsor communications in approximately 40% of cases. References FDA.
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