FDA Clinical Inspection Summary for Pfizer's Ibrance

FDA did not post any warning letters this week to Sponsors/Monitors/CROs, IRBs or clinical investigators. From the archives, here is the inspection summary for Pfizer's Ibrance. One investigator received a 483. Although the eight pages of details around that five item 483 were redacted, in summary Dr. Fin was cited for:

  • Protocol Deviations
  • Discrepancies between source documents and CRF entires for adverse events, concomitant medications and doses of investigational product
  • Two subjects were not consented with the most recent IRB-approved Informed Consent. Three subjects were not reconsented as required by the IRB.
  • Investigational Product discrepancies with the number of doses taken by a single patient
  • The FDA Form-1572 was not updated to include two subinvestigators
  • One subject did not meet inclusion criteria
  • Two subjects were not randomized correctly
  • Laboratory safety assessments were not performed as required for six subjects
  • One serious adverse event was reported within 2 days instead of the 24 hours required by the protocol
  • Three subjects had pharmacokinetic samples collected out of window