FDA did not issue any warning letters to Sponsors/Monitors/CROs, Clinical Investigators or IRBs this week. From the archives, here is the Clinical Inspection Summary for Corlanor (ivabradine) submitted by Amgen. Five sites, out of 677 participating sites, were selected by FDA for inspection. Selection was based on enrollment, high treatment effect and low numbers of SAEs. Site inspections lasted 3-4 days.
Dr. Gersamija received a 483 for:
- Failing to follow the investigational plan, specifically not reporting serious adverse events (SAEs) immediately to the sponsor as required by the protocol. Four SAEs were reported 4 to 19 days late.
Dr. Marchev received a 483 for:
- Failing to follow the investigational plan, specifically:
- Source documentation for an adverse event of high heart rate was not consistent with changes made to the Case Report Form (CRF).
- One subject received an excluded concomitant medication for two weeks.
- Randomization records did not match source records for one subject with regards to a concomitant medication.
Dr. Opris received a 483 for:
- Failing to follow the investigational plan, specifically two subjects received excluded concomitant medications.