FDA hold on Ortho RTI’s regenerative drug lifted, trials to resume

The FDA’s clinical hold on Ortho RIT’s Ortho-R drug has been lifted, according to a Dec. 13 news release.

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Ortho RTI received a clinical hold letter for Ortho-R, a regenerative product for rotator cuff repairs in June.

After addressing concerns, the company was cleared to proceed with clinical trials for Ortho-R. Ortho RTI plans to enroll 78 patients across 10 clinical sites for the trial.

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