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FDA: reporting thresholds for unspecified impurities in oligonucleotides should be justified case‑by‑case
Summary
Dr. Liang told attendees that reporting thresholds for unspecified impurities in oligonucleotides should be set below the identification threshold, determined case‑by‑case with consideration of method sensitivity (LOQ) and justified to reviewers.
A questioner asked whether the peptide reporting limit (not more than 0.10%) can be used for oligonucleotides. Dr. Liang said the reporting threshold should be lower than the identification threshold and that identification thresholds for oligonucleotides are determined on a case‑by‑case basis.
"So the, reporting threshold, should be lower than typically, it should be lower than the identification threshold," Dr. Liang said. He explained that identification thresholds involve risk assessments and method sensitivity; sponsors should propose a reporting threshold justified by method LOQ and supporting data for review rather than relying on a single numeric default.
The agency invited sponsors to propose thresholds with scientific justification; reviewers will assess those proposals during the review process.
