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# Ortho Regenerative Submits Response to Ortho-R Clinical Hold
- URL: https://www.fdaweb.com/ortho-regenerative-submits-response-to-ortho-r-clinical-hold/
- Published: 2021-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:06:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149749

Ortho Regenerative Technologies says it has provided all chemistry, manufacturing, and control (CMC)-related data and characterization information requested by FDA as part of the agency’s clinical hold on the IND application for Ortho-R, a drug/biologic combination product candidate used as an adjunct to improve the success rate of standard of care surgery in rotator cuff tear repair. The company [says](https://www.marketwatch.com/press-release/ortho-regenerative-technologies-submits-formal-response-to-us-fda-clinical-hold-2021-07-20?tesla=y&ref=fdaweb.com) FDA requested the additional CMC-related data and characterization in its 6/2021 clinical hold letter.

Ortho says it is confident that the data submitted, complementary new information, and test results will address FDA’s requests.