FDA WARNING_LETTER - AB Science - September 26, 2014

On June 16, 2015, the FDA issued a Warning Letter to AB Science CEO Alain Moussy, following a September 22-26, 2014 inspection. The inspection, part of the Bioresearch Monitoring Program, reviewed AB Science's conduct as sponsor for clinical investigations of investigational drug (b)(4) under Protocols (b)(4), (b)(4), and (b)(4).

The FDA concluded that AB Science failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Key violations include:

1. **Failure to ensure proper monitoring and adherence to protocols [21 CFR 312.50 and 312.56(a)]**: * **Inadequate SAE reporting**: Monitors failed to identify and correct clinical investigators' failure to report Serious Adverse Events (SAEs) within protocol-specified 24-hour timeframes for Protocols (b)(4), (b)(4), and (b)(4). Examples include delays of years in reporting thrombocytopenia and leukopenia, and unreported hospitalizations. AB Science's proposed corrective action plan, including training, was deemed inadequate for lacking provisions to assess effectiveness and ensure sustained compliance. * **Failure to perform protocol-required laboratory tests**: Monitors failed to identify and correct investigators' failure to perform required hematologic laboratory tests (e.g., for neutropenia monitoring