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FDA lists common deficiencies in extractable and leachable submissions
Summary
OGD reviewers highlighted recurring problems—failing to consider worst‑case maximum daily dose, missing safety justifications, inadequate characterization, and inappropriate use of nonvalidated in silico methods—that trigger review deficiencies.
Vince Crowley listed common reasons OGD issues review deficiencies on extractable/leachable packages: not using worst‑case maximum daily dose (MDD), failing to include safety justifications, not adequately characterizing extractables/leachables, and relying on nonvalidated in silico methods for endpoints beyond mutagenicity.
"Not considering the worst case scenario, maximum daily dose or MDD," Crowley said, noting applicants must account for multiple dosing regimens or patient populations and choose the highest plausible exposure when calculating maximum daily exposure. He also warned that tools such as certain in silico classifiers are not currently accepted for regulatory toxicology beyond mutagenicity endpoints.
