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 Iluvien (flucinolone acetonide intravitreal insert) submitted by Alimera. Two sites were selected for inspection, based on enrollment, high numbers of IND trials at sites and lack of previous inspectional history. Site inspections ranged over 11 to 14 days. Both sites received FDA Form 483s.
Dr. Blackburn was cited for failing to prepare and maintain adequate and accurate case histories, specifically source documents were missing for combined visits.
Dr. Garg was cited for failing to report unanticipated problems to the IRB, specifically that the following protocol deviations were not reported:
- One subject did not have Intra-ocular pressure (IOP) re-measured as the protocol required
- Failing to complete a specific follow up assessment at month 6 (optical coherence tomography (OCT))
- Use of a prohibited concomitant medication