Randy J. Epstein, M.D./Chicago Cornea Consultants, Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with investigational new drugs that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)].

Passage 2

You failed to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug [21 CFR 312.57(a)].

Passage 3

You failed to adhere to this requirement. Specifically, for Protocol PXL-330, you failed to maintain adequate records showing the receipt, shipment, and other disposition of the investigational drugs riboflavin 0.25% transepithelial solution and riboflavin 0.1% hypotonic solution.