FDA 483 - Cidara Therapeutics, Inc. - November 16, 2022

An FDA inspection of Cidara Therapeutics, Inc. in San Diego, CA, a sponsor of clinical studies, identified two observations related to inadequate monitoring of serious adverse events (SAEs). The firm failed to ensure proper monitoring of study conduct, leading to late reporting of SAEs and a lack of deviation documentation. Additionally, monitoring failed to identify and document deviations for clinical investigators not signing off on SAE forms, preventing verification of causality assessments.