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FDA OGD lays out extractable and leachable review priorities
Summary
Speakers from FDA—s Office of Generic Drugs outlined how applicants can leverage prior knowledge, follow USP and CFR references, and set safety thresholds to avoid unnecessary extractables/leachables testing in regulatory submissions.
Xing Su, a senior chemist and reviewer in FDA—s Office of Material Quality, and Vince Crowley, a senior pharmacologist in OGD—s pharm/tox division, presented an overview of extractables and leachables and how the agency evaluates related data in submissions. Su said the session focused on "strategy how to not to perform a... eligible study," emphasizing risk‑based approaches that can reduce time and cost for applicants.
"We all know what extractable literables are, And, we know that intrapals are actually compounds that it that it's trapped into a solvent in a laboratory conditions," Su said, distinguishing extractables (identified under exaggerated lab conditions) from leachables (compounds that appear in the drug product under normal storage/use). Crowley added that OGD evaluates leachables observed above safety thresholds for mutagenicity, general toxicity, and local toxicity in the context of the specific drug product.
