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  1. Center for Biologics Evaluation and Research (CBER)

PREA Non-Compliance Letters

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
In accordance with section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act of 2012 (Pub. L. No. 112-144), the following table identifies drug and biologic products for which the sponsor has received a PREA Non-Compliance letter and provides links to the PREA Non-Compliance letter and sponsor response (with redactions for trade secret or confidential commercial information).

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation. Section 505B(d)(1) further requires FDA to post the PREA Non-Compliance letter and sponsor’s response.

If a sponsor has requested a deferral extension in accordance with 505B(a)(3)(B)(i), FDA does not intend to post a PREA Non-Compliance letter or sponsor’s response until we have determined whether to grant or deny the deferral extension request. If we have granted a sponsor’s deferral extension request and the extended deferral date has not yet passed, neither a PREA Non-Compliance letter nor a sponsor’s response will be posted.

If a sponsor has requested a waiver in accordance with 505B(a)(4), FDA does not intend to post a PREA Non-Compliance letter or sponsor's response until we have determined whether the letter was issued in error. If we have granted a sponsor's waiver request then the PREA Non-Compliance letter and sponsor's response will not be posted.

When the sponsor fulfills or is otherwise released from the requirement to conduct the study(ies), CBER will add the date the requirement is fulfilled or released to the last column of the table.
For more information about the current status of a specific PREA postmarketing requirement (pediatric study), please visit: http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm.

 

 Sponsor Product Non-Compliance Letter Sponsor's Response Comments

SmartPractice Denmark ApS

Thin-Layer Rapid Use Epicutaneous Patch Test (T.R.U.E. TEST)

5/11/165/31/16 Fulfilled 8/25/17
Organogenesis, Inc.Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT)6/29/178/17/17 

 

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