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 Cinqair (reslizumab) submitted by Teva. No sites were selected for inspection, as all study sites worldwide had very low enrollment. The sponsor, Teva, was inspected. No form 483 was issued; however the inspectors were instructed to look at four specific items during the sponsor inspection.
- The inspection was directed to focus on the data fields that were changed post database lock. FDA also noted that the statistical analysis plan for the two studies was finalized after the first database lock, but before study unblinding.
- The inspection directed to investigate the process for adjudication of Clinical Events. FDA noted that the submitted eCRF data fields did not appear to be complete enough for proper adjudication.
- Subjects who were excluded from the safety database were examined closely to determine the incidence of adverse events.
- The inspection looked carefully at adverse events that FDA noted were of concern during the FDA's review of the submission.