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.