Ortho Regenerative Technologies has submitted requested data related to its Ortho-R drug to the FDA after the company paused its clinical trial.
Ortho RTI shared additional chemistry, manufacturing and control information to the FDA, according to a July 20 news release.
The data is a response to a clinical hold letter the FDA sent Ortho RTI in June regarding Ortho-R, a biologic drug. Ortho-R received classification as a biologic drug last year.