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.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
