IP accountability

FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. 

Dr. Khan was warned for failing to retain records, specifically:

  • IP accountability
  • Informed consents
  • Case histories

FDA notes that the PI misunderstood the record retention requirements to be two years after the termination of the study at the site, as opposed to two years beyond the last marketing application. 

FDA Clinical Inspection Summary: Moxifloxacin (alternative formulation) submitted by Alcon

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 Moxifloxacin (alternative formula) submitted by Alcon. Two sites (out of 32 participating sites) were selected for inspection, on the basis of enrollment and their operation under a site management organization. Site inspections ranged over seven and ten days. One site received a FDA Form 483.

Dr. Christiansen was cited for:

  • Failing to maintain adequate IP accountability
    •  Received by dates in the IP log were incorrect for thirteen subjects
    • Return information was missing or left  blank for two subjects
  • Failing to follow the investigational plan
    • Age specific tests were not conducted for one subject
  • Failing to prepare and maintain adequate and accurate case histories
    • Three discrepancies were noted between source documents and the CRF

FDA Clinical Inspection Summary: Mavyret (glecaprevir/pibrentasavir-ABT-493+ABT-530) submitted by Abbvie

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 Mavyret (glecaprevir/pibrentasavir-ABT-493+ABT-530), submitted by Abbvie. Seven sites were inspected. Inspections ranged from three to seven days. Two sites received FDA Form 483s.

Dr. Jazrawi was cited for:

  • Inadequate documentation to support one subject met inclusion criteria for two lab values

Dr. Zogg was cited for:

  • Lack of documentation to support kit numbers dispensed and returned. (NOTE: FDA notes that the investigator stated that this function was performed by the Interactive Response Technology provider contracted by the sponsor, but FDA still issued the 483 to the site. FDA further notes that the investigator submitted an acceptable corrective action plan.)

FDA Clinical Inspection Summary: Nerlynx (neratinib maleate) submitted by Puma

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 Nerlynx (neratinib maleate) submitted by Puma. Four sites plus the sponsor were inspected. Site inspections ranged from two to five days, and the sponsor inspection lasted 3 days. Two sites received FDA Form 483s.

Dr. Chan was cited for:

  • Failing to maintain accurate investigational product accountability records. FDA notes that at a time when the IVRS system was down, the site called the IVRS helpdesk for a manual assignment over the phone. The kit assigned over the phone differed that a faxed kit number subsequently sent to the site.

Dr. Tomasevic was cited for:

  • Failing to report adverse events that appeared in subject diaries for three subjects. 

FDA Clinical Inspection Summary: Pomalyst (pomalidomide) submitted by Celgene

FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or Clinical Investigators. From the archives, here is the Clinical Inspection Summary for Pomalyst (pomalidomide) submitted by Celgene. Three sites plus the sponsor were selected for inspection based on the submission of a single Phase 1/2 study. Site inspections ranged from six to twenty days and the sponsor inspection ranged over one month. One site and the sponsor received an FDA Form 483.

Dr. Siegel was cited for failing to maintain adequate investigational product accountability. Specifically, the records for three subjects did had discrepancies of two to five capsules. 

Celgene was cited for the following:

  • Inadequate monitoring of the study
    • The monitoring plan required investigational product accountability to be performed at every visit.
    • FDA review of monitoring visit reports determined that for three sites investigational product accountability was done at half or less than half the visits.
    • Four monitoring visit reports lacked a description of investigational product accountability activities by the monitor at the visit. 
    • Investigational product accountability records lacked lot numbers and quantities of investigational product destroyed by a third party. 
  • Inadequate labeling of investigational product
    • The investigational drug labeling lacked directions to the patient to take at least two hours before or after eating.