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 Zurampic (lesinurad) submitted by Ardea Biosciences. Two pivotal studies (301 and 302) were submitted in the NDA. Two sites in the 301 study and one site in the 302 study were inspected based on high enrollment and FDA's determination that the responder rate variability at sites could impact the treatment efficacy results of the submitted trials. The sponsor was also selected for inspection. Site inspections ranged over 6-10 days. Two sites received 483s.
Dr. Drummond received a 483 for:
- Randomizing a subject with exclusionary laboratory values
- One subject was not reconsented with an updated informed consent document that contained new safety information.
- The site could not account for a total of 22 kits of investigational product or placebo returned by five subjects.
Dr. Miller received a 483 for:
- Enrolling one subject who experienced an exclusionary gout flare within 7 days of enrollment, contrary to protocol requirements.