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BioWorld - Friday, May 8, 2026
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Home » FDA issues clinical hold on Ortho's IND application for Ortho-R clinical trial
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FDA issues clinical hold on Ortho's IND application for Ortho-R clinical trial

June 4, 2021
By Annette Boyle
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
Clinical Medical technology Regulatory Orthopedics Canada FDA IND

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