Issue link: https://www.e-digitaleditions.com/i/1514991
10 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Regul ations in the eCTD Module 3 section 3.2.S.3.2 for the drug substance. Files containing supporting data can be placed in Module 3.2.R (e.g., (Q)SAR output reports) and nonclinical study reports (e.g., Ames studies) sub- mitted in Module 4. It is helpful if hyperlink(s) to the SD File submitted in Module 3 are provided to assist cross-referencing between eCTD modules. Benefits of the SD File for CMC review There are significant benefits to submitting chemical structures in a single SD File for use by multiple groups within FDA/CDER and OC. Figure 3 outlines how a single structure in a DMF submission could move through FDA/CDER and OC during the review process. For example, FDA's GSRS registrars identif y SD Files that have been submitted by industry through the ESG. Registrars identif y str uctures that have existing UNIIs, verify structures, assign new UNIIs to new structures, and link associated data fields to each str ucture for traceabilit y. In addition, regis- tered structures are included in OPQ's Knowledge Aided Structured Assessment (KASA) framework so that cross-functional regulatory review assessment is enabled. KASA is a Federal Information Security Management Act (FISMA) High, highly secure in- ternal database, that is only accessible to authorized FDA/CDER assessors. This single registration results in greater efficiency in the DMF review process since the structure needs only to be registered once for use across multiple groups. Another benefit of the SD File format is that the structure images can be easily copied by assessors for inclusion in corresponding review documents or internal consultation request forms. In addition, assessors in the Computational Toxicology Consultation Ser vice (CTCS) group can rapidly import the SD File into (Q)SAR software to generate toxicological predictions, as needed. Finally, submission of the SD File results in fewer typographi- cal errors that could be propagated as multiple groups re-draw the same structure for their own review or databasing purposes. Frequently asked questions and additional supporting information Table I provides a list of frequently asked questions (FAQs). Conclusion Submission of structures as PDF files requires end FIGURE 3. Groups that use the structure-data file (SD File) in FDA/CDER and OC. Submission of structures as PDF files requires end users at FDA/CDER to manually re-draw each structure for review and cheminformatics purposes.