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 Eucrisa (crisaborole) submitted by Anacor Pharms Inc. Two pivotal studies were included in the New Drug Application (NDA). The first was conducted at 48 sites and the second was conducted at 42 sites. Four sites were selected for inspection based on high enrollment and high number of treatment responders. Site inspections ranged over one to eight days. One site received a FDA Form 483.
Dr. Williams was cited for:
- Two subjects used prohibited concomitant medications while on the study