FDA WARNING_LETTER - Doft, Bernard H. M.D. - September 28, 2012

This FDA Warning Letter, Ref: 13-HFD-45-05-01, dated June 12, 2013, was issued to Bernard H. Doft, M.D., following an inspection from September 17-28, 2012. The inspection reviewed Dr. Doft's conduct of clinical investigation Protocol FVF4579, "A Phase III, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-Needed Basis (PRN) in Patients with Subfoveal Neovascular Age-Related Macular Degeneration," for the investigational drug ranibizumab (Lucentis®) performed for Genentech, Inc.

The FDA identified three main violations of statutory requirements and FDA regulations:

1. **Failure to conduct the investigation according to the investigational plan [21 CFR 312.60]:** * Two subjects (704201, 704220) were enrolled despite not meeting the required BCVA inclusion criteria (20/40-20/320 Snellen equivalent). * BCVA was measured by uncertified personnel for 5 subjects (704201-7