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FDA panel clarifies when injectables trigger petitions and PREA waivers
Summary
Panelists said a change in fill volume for an injectable requires a suitability petition if the RLD lacks that fill volume because injectables can change total drug content; panelists also explained that most suitability-petition allowable changes—except strength changes—trigger PREA waiver considerations.
An audience member asked whether a change in fill volume for an injectable product always requires a suitability petition and which changes trigger the Pediatric Research Equity Act (PREA) waiver process.
Rosie Pagaduan replied that "a change in fill volume would require a suitability petition if the RLD does not have that fill volume," because for parenteral products a change in fill volume can change total drug content or concentration. On PREA, Andrew (Agency official, S3) explained that "all changes except strength changes would trigger PREA and require a waiver request within that suitability petition," while strain changes proposed in a suitability petition do not trigger PREA.
Andrew described the waiver process as an internal FDA committee review that includes pediatricians and regulatory experts who evaluate whether a proposed change is likely to be used in pediatric populations. The panel said waiver decisions are handled internally and applicants should include waiver requests when PREA is triggered.
