PREA Non-Compliance Letters
In accordance with section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the following table identifies drug and biological products for which the sponsor has received a Non-Compliance letter and provides links to the Non-Compliance letter and sponsor’s response (with redactions for trade secret or confidential commercial information). These letters have been issued under provisions of the Pediatric Research Equity Act (PREA), which amended the FD&C Act, and are commonly referred to as “PREA Non-Compliance letters.
Consistent with section 505B(d)(1) of the FD&C Act, FDA has issued a PREA Non-Compliance letter to a sponsor if it failed to submit within the required timeframe a required pediatric assessment or report of a molecularly targeted pediatric cancer investigation (as appropriate) (usually in the form of a supplemental application that includes proposed labeling). FDA has also issued such a letter if a sponsor failed to request approval for a pediatric formulation as described in section 505B(a) or 505B(b) of the FD&C Act. Consistent with section 505B(d)(1), FDA has also made publicly available on FDA’s website the PREA Non-Compliance letter and sponsor’s response with certain redactions.
If a sponsor has requested a deferral extension in accordance with section 505B(a)(4)(B)(i), or submitted a waiver request in accordance with section 505B(a)(5), by the due date of the pediatric assessment or the report of the molecularly targeted pediatric cancer investigation, FDA has not issued a PREA Non-Compliance letter unless FDA subsequently denied the deferral extension or waiver request.
Further, if FDA has determined that a PREA Non-Compliance letter was issued to the sponsor in error (e.g., a waiver was granted prior to the due date of the pediatric assessment or report of the molecularly targeted pediatric cancer investigation), then neither the PREA Non-Compliance letter nor the sponsor’s response have been posted.
Where the sponsor has fulfilled or has otherwise been released from the requirement to conduct one or more pediatric assessments or molecularly targeted cancer investigations, FDA has added the date the requirement was fulfilled or released to the last column of the table. For more information about the current status of a specific PREA postmarketing requirement (i.e., a required pediatric assessment or molecularly targeted pediatric cancer investigation that was deferred until some point after the product’s approval), please visit Postmarket Requirements and Commitments.
| Sponsor | Product | Non-Compliance Letter | Sponsor's Response | Comments |
|---|---|---|---|---|
|
SmartPractice Denmark ApS |
Thin-Layer Rapid Use Epicutaneous Patch Test (T.R.U.E. TEST) |
5/11/16 | 5/31/16 | Fulfilled 8/25/17 |
| Organogenesis, Inc. | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT) | 6/29/17 | 8/17/17 | |
|
GlaxoSmithKline Biologicals |
Meningococcal Group B Vaccine (Bexsero ®) | 4/16/18 | 4/25/18 List A & B Request for Extension |
Deferral extension was granted 6/7/18 |
| Wyeth Pharmaceuticals, Inc. | Meningococcal Group B Vaccine (TRUMENBA ®) | 7/8/21 | 7/22/21 Correspondence Regarding Postmarketing Requirements |
Released & Replaced (5/24/22) |
| OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. | von Willebrand Factor/Coagulation F VIII Complex | 9/8/21 | ||
| Medexus Pharma, Inc. | Coagulation Factor IX (Recombinant). | 1/25/22 |
Request for Deferral of Pediatric Studies - Medexus Pharma, Inc. |
Deferral extension was granted 7/26/22 |
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