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FDA presenter encourages structured SD files to remove ambiguity in chemical structure submissions
Summary
Agency official said submitting structured chemical-structure (SD) files with Type 2 DMFs helps the agency use machine-readable representations to ensure the structure assessed is the structure intended, reducing duplication of work.
The presenter said the agency has seen an increase in structured data (SD) file submissions for Type 2 DMFs and encouraged their use because they provide unambiguous chemical-structure information in a machine-readable mole-connection table. "It ensures that the structure that you intend for us to assess is the 1 that we're assessing," the Agency official said.
She noted a short SD-file guide is available for those who have not submitted such files before and urged applicants to consider SD submissions to expedite assessment and reduce duplicative work during review.
