FDA WARNING_LETTER - Thomas S. Tooma, M.D. - July 17, 2015

On November 2, 2015, the FDA issued a Warning Letter to Thomas S. Tooma, M.D., of NVISION Laser Eye Centers, following an inspection from June 29 to July 17, 2015. The inspection reviewed Dr. Tooma's conduct as sponsor-investigator for the "Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 in Eyes with Keratoconus or Ectasia," involving investigational riboflavin ophthalmic solution (0.1% and 0.25%).

The FDA identified three significant violations: 1. **Failure to Submit an IND:** Dr. Tooma failed to submit an Investigational New Drug (IND) application for the riboflavin ophthalmic solution, which is considered a drug under the FD&C Act and was not lawfully marketed or exempt from IND requirements. The study, initiated in September 2012, enrolled subjects at a minimum of seven sites. Dr. Tooma's response, citing lack of awareness and humanitarian use, was deemed inadequate as no IND had been submitted. 2. **Failure to Ensure Proper Monitoring:** Dr. Tooma failed to ensure proper monitoring of the clinical investigation, acknowledging he did not have a monitor. His proposed plan to hire an experienced monitor was inadequate due to lack of a timeline and specific details. 3