FDA WARNING_LETTER - "David M. Lubeck, M.D./Arbor Centers for EyeCare - April 20, 2022

The FDA issued a Warning Letter to Dr. Lubeck following an inspection from April 12-20, 2022, under the Bioresearch Monitoring Program. The inspection reviewed Dr. Lubeck's conduct as sponsor-investigator for clinical investigations.

The primary violation identified was the failure to submit an Investigational New Drug (IND) application for a clinical investigation involving a combination product of investigational drugs (b)(4) and (b)(4) in combination with (b)(4), conducted under Protocol (b)(4). Five human subjects were enrolled in this study without an IND in effect, violating 21 CFR 312.20(a), 312.20(b), and 312.40(a).

Dr. Lubeck's May 10, 2022, response claimed the study was a nonsignificant risk (NSR) device study, with (b)(4) as a GRAS substance, and an IDE was not required. However, the FDA determined the product was a combination product with a drug primary mode of action, thus requiring an IND. Although enrollment was halted after an IRB notified Dr. Lubeck an IND was required, the IND subsequently submitted (containing Protocol (b)(4)) did not cover the initiated study (Protocol (b)(4)). Furthermore, an IND generally goes into effect 30 days