Regulatory Focus™ > News Articles > FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

Posted 18 August 2017 | By Zachary Brennan 

FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

FDA said in a letter sent to the company in late July that it has not yet submitted its pediatric assessment, which was identified in the BLA’s approval letter from March 2012.

“Therefore, we are hereby notifying you that due to your failure to submit either a pediatric assessment or a request for a deferral extension, you are not in compliance with federal law. Under the provisions of title V, section 505, of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), you must respond in writing within 45 calendar days of the date of this letter,” FDA said.

The agency is seeking “the reason(s) for the delayed pediatric assessment and a date by which you expect to submit the assessment. You may also include a request for a deferral extension.”

Organogenesis did not respond to a request for comment.


Under FDAISA, FDA is required to send a PREA non-compliance letter to sponsors who have failed to submit their pediatric assessments required under the law 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. FDA is also required to post the non-compliance letter and the sponsor’s response.

If a sponsor has requested a deferral extension, FDA says it does not intend to post the non-compliance letter or sponsor’s response until it has determined whether to grant or deny the deferral extension request. If such an extension is granted and the extended deferral date has not yet passed, neither the letter nor a sponsor’s response will be posted.

If a sponsor has requested a waiver, FDA also says it does not intend to post a non-compliance letter or sponsor's response until it determines whether the letter was issued in error.

When the sponsor fulfills or is otherwise released from the requirement to conduct the study(ies), FDA says it will add the date the requirement is fulfilled or released. For more information about the current status of a specific PREA postmarketing requirement, FDA points sponsors to:

SmartPractice Denmark ApS is the only other company currently listed on FDA’s PREA non-compliance letters page, and the company has responded.

Categories: Regulatory News

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