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

Source: https://www.keypedia.com/records/warning_letter/doft-bernard-h-md/d09ec772-f505-45b0-b26e-a850cbc40f34

> FDA WARNING_LETTER for Doft, Bernard H. M.D. on September 28, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Doft, Bernard H. M.D.
- Inspection Date: 2012-09-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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Company: https://www.keypedia.com/companies/doft-bernard-h-md/dc4d25ba-4abf-4fa8-b96a-6dd1627ff82f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c