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FDA: PREA waiver may be required for some suitability petitions; denial possible if waiver unavailable
Summary
FDA staff said petitioners must request a PREA waiver when a suitability petition triggers Pediatric Research Equity Act requirements; if FDA cannot waive PREA the suitability petition will be denied and the ANDA pathway will be blocked.
Karen Rothschild told attendees that some suitability petitions will trigger Pediatric Research Equity Act (PREA) requirements and that petitioners must request a waiver when required.
"You will need to request a waiver of the requirements of the Pediatric Research and Equity Act, which is known as PREA," Rothschild said, warning that if FDA cannot waive PREA the suitability petition will be denied and the ANDA pathway would not be appropriate.
Rothschild contrasted this with strength-only petitions, which under the updated guidance are automatically waived from PREA requirements (petitioners do not need to submit a separate PREA waiver for strength-only changes). She advised applicants to consult the May 2023 guidance for precise citation language and documentation to include with a waiver request.
