FDA EIR - Novartis Pharmaceuticals Corporation - March 02, 2017

An FDA inspection of Novartis Pharmaceuticals Corp. was conducted from February 23 to March 2, 2017, at its East Hanover, NJ facility. This pre-announced inspection, initiated by the Center for Drug Evaluation and Research, focused on the company’s conduct of a Phase 3 clinical trial (protocol CLEE011A2301, supporting NDA #209092) for advanced breast cancer treatment, under the regulatory framework for sponsors and contract research organizations.

During the inspection, several areas for improvement were identified. Three monitoring reports from one of 23 reviewed clinical sites were found not to have been properly uploaded into the firm’s computer database, indicating a deviation from their "Working Practices for Monitoring" document. While this did not apparently impact subject protection or data integrity, it was a point of discussion. Furthermore, one of 46 required 15-day expedited Serious Adverse Event reports was submitted 40 days late due to an administrative error. The inspection also highlighted the importance of providing up-to-date information regarding subjects' vital status and maintaining current contact information in regulatory submissions, as outdated details had hindered pre-announcement of the inspection.

No Form FDA-483 was issued to Novartis. However, the investigator formally reminded management of these observations, particularly regarding adherence to monitoring procedures, timely expedited reporting, and accurate contact information. Novartis management acknowledged these discussion points and indicated they would take them into consideration for appropriate action.