FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for IDHIFA (enasidenib) submitted by Celgene. Three sites plus the sponsor were inspected. Site inspections ranged from three to five days and the sponsor inspection took place over 4 days. One site received a FDA Form 483.
Dr. Kantajian was cited for failing to follow the investigational plan, specifically:
- Failing to report a headache and a fall in one subject that resulted in a visit to the emergency room.
- Failing to report hospitalization for nausea and vomiting within twenty four hours as required by the protocol
Page 236 here has the data request showing information FDA expected within five days regarding sites to be potentially inspected.
Page 127 here shows the FDA requiring analysis excluding subjects who did not have a positive result based on the companion diagnostic.