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FDA: leverage prior knowledge, USP standards to reduce leachables testing
Summary
FDA presenters advised applicants to consult CCS vendors, use prior product data, and rely on USP <1663>/<1664> and 21 CFR materials specifications to avoid unnecessary extractable/leachable studies when justifiable.
Xing Su urged applicants to perform product‑specific risk assessments and to contact CCS vendors for composition and processing details before designing extractable/leachable studies. She advised looking up prior approvals and internal databases to see if the same CCS and similar formulations already exist and can support a new application.
"USP 1663 and USP 1664 are very valuable, references," Su said, and she emphasized that applicants must provide material specifications and test results showing CCS construction and use conditions are consistent with the cited regulations (21 CFR 174—6).
