Neuralight Hit With Warning Letter for Testing Without IND Approval

Neuralight has earned a warning letter from the FDA for testing an investigational drug on human subjects without IND approval.

A May investigation revealed that the company administered the unapproved product to 20 subjects without going through the formal IND application process.

“By exposing human subjects to a new, unapproved drug without obtaining an IND, Neuralight jeopardized the safety of those subjects,” the letter chides.