Successfully Prepare Structure-Data Files For Regulatory Submissions

Sponsors must now provide the FDA with an electronic record of chemical structures using the eCTD format, specifically as a single structure-data file (SD file) for New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Drug Master Files (DMFs) within the FDA's KASA review program.

Additionally, it is highly recommended to submit SD files for other Chemistry, Manufacturing, and Controls (CMC) submissions. The SD file format is designed for computer readability, streamlining the regulatory review process by eliminating the need for manual structure drawing. This format facilitates efficient chemical registration, computational analyses, and easy extraction of structures for further review, ultimately saving time for regulatory reviewers.

Review the guidelines outlined in this infographic to ensure a successful SD file for regulatory submissions.