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 Vyzulta (latanoprostene bunod) submitted by Bausch & Lomb. Two sites were selected for inspection, based on large enrollment and lack of recent inspections. One site received a FDA 483.
Dr. Christie was cited for failing to store Study drug per protocol. FDA notes that the refrigerator which stored study drug was required to be between two degrees and eight degrees Celsius. There were at least 31 days when the refrigerator was below this range, and nineteen days when the temperature was not recorded.
FDA also posted two complete response letters associated with this application. Complete responses cited manufacturing issues noted during inspections requiring correction.
During the approval process, FDA noted and required:
- Missing pages from a batch record be submitted
- Subjects with more than one baseline value in the dataset be explained
- Subjects who discontinued due to potential lack of efficacy should be identified in the data, including specific subjects that FDA identified within the data as experiencing lack of efficacy
- Randomization errors be listed in the patient disposition table