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# FDA Says Organogenesis Owes a Gintuit Pediatric Study
- URL: https://www.fdaweb.com/fda-says-organogenesis-owes-a-gintuit-pediatric-study/
- Published: 2017-08-22T12:00:00.000Z
- Updated: 2026-09-14T22:42:43.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139440

FDA says that Organogeneris has failed to submit a pediatric assessment for its Gintuit (allogenic cultured keratinocytes and fibroblasts in bovine collagen) allogenic oral soft tissue product as required under the Pediatric Research Equity Act (PREA). The need for the study was included in the agency’s 3/9/12 BLA approval letter. The company was given 45 days to respond to the just-released 6/29 FDA [notification](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/UCM572082.pdf?ref=fdaweb.com) of non-compliance with PREA.