FDA WARNING_LETTER - Nasr, Samya, M.D. - August 25, 2009

The FDA issued a Warning Letter to Dr. Samya Nasr following an investigation between July 20 and August 25, 2009, reviewing her conduct of six clinical investigations for investigational drugs Aztreonam Lysinate, Denufosol Tetrasodium, and ALTU-135. The inspection, part of the Bioresearch Monitoring Program, found Dr. Nasr failed to adhere to statutory requirements and FDA regulations for clinical investigations, specifically regarding human subject protection.

Key violations include: 1. **Failure to obtain informed consent (21 CFR part 50, 21 CFR 312.60):** * For Protocol CP-AI-005, the informed consent form (ICF) incorrectly stated the study purpose, implying Aztreonam Lysinate could stop *P. aeruginosa* recurrence, which was not proven. Despite sponsor notifications and IRB approval of revised ICFs, six subjects were not properly reconsented, and required documentation (e.g., pregnancy test notification, reconsenting requirement) was inconsistent or absent. Handwritten notes were added to consent forms, and copies varied between records. * For Protocol 08-108, no ICFs were found for two subjects who underwent study-related screening procedures. * For Protocol 08-110, ICFs for three subjects lacked checkmarks for P2Y2