Sponsor-Investigator Issued Warning Letter Over Failure To Submit IND for Combination Product
November 30, 2022 at 04:13 PM EST
An Illinois ophthalmologist was issued a Nov. 18 FDA Warning Letter for failing to submit an Investigational New Drug application (IND) to conduct a clinical investigation with investigational new drugs.
In response to a May 2022, written response to a Form FDA 483, the ophthalmologist – David Lubeck, who is associated with the Arbor Centers for EyeCare in Orland Park, Ill. –... Read More
