Ortho RTI submitted an investigational new drug application to begin phase 1 and 2 trials for Ortho-R. The FDA requested additional information related to chemistry, manufacturing and control. Ortho RTI plans to provide the information and testing data to the FDA within the next four to six weeks.
“We will work diligently to address the FDA’s questions as quickly as possible and look forward to continuing to work closely with them to secure IND approval,” president and CEO Claude LeDuc said.
Last year, Ortho-R was classified as a biologic drug. Ortho RTI had planned to start clinical trials later this 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.
