Drugs

IND Not Submitted for Cornea Associates Trials: FDA

A 9/12-9/19/22 FDA inspection at Cornea Associates of Texas, in Dallas, TX, found “objectionable conditions” in the facility’s role as the sponsor and Dr. Tyrone McCall’s role as the authorized representative of the sponsor and clinical investigator for two clinical investigations. A 3/22 Warning Letter says the inspection was part of FDA’s Bioresearch Monitoring Program. The specific violation noted in the letter was failing to submit an IND application for the conduct of a clinical investigation with investigational new drugs.

The letter says Cornea Associates indicated it misunderstood the IND exemption requirements in regulations and said the error was discovered upon further review with an institutional review board and the study enrollment was immediately stopped. It also said it submitted an IND 12/6/19.

“While we acknowledge that Cornea Associates immediately stopped enrollment upon discovering that a sponsor had to submit, and to have in effect, an IND before conducting a [redacted protocol], we reiterate that the combination product consisting of investigational drugs is not a lawfully marketed product in the U.S. and therefore did not qualify for an IND exemption,” the letter says. The letter also notes that Cornea Associates, and not an institutional review board, is responsible for complying with IND regulations.

FDA says the firm’s response with a corrective and preventive action plan was inadequate because it did not provide sufficient details about how Cornea Associates would determine when an IND is required for clinical investigations of products regulated by FDA and how it would comply with IND regulations.

“Cornea Associates’ failure to submit, and to have in effect, an IND before initiating its clinical investigation with investigational drugs raises significant concerns regarding the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of data collected during the conduct of the investigation,” FDA says.

The firm was told to respond with a list of specific actions it has taken to prevent similar violations in the future.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome