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Commander Fung: justify deviations in Modules 2.7 or 5; PAS filing review treated like original ANDA
Summary
Commander Fung said justifications for deviating from product-specific guidance during filing review should be provided in Module 2.7 or Module 5, and that a Prior Approval Supplement (new strength PAS) undergoes the same filing-review approach as an original ANDA.
In response to questions about how to justify deviating from product-specific recommendations after an ANDA submission, Commander Fung said such justifications can be included in Module 2.7 or Module 5 of the submission, particularly where the approach concerns bioequivalence (BE) methodology. "A justification... can be provided in module 2.7 or module 5 to show... what method you're using to demonstrate bioequivalence for your drug product," he said.
On whether filing review differs when submitting a new strength as a Prior Approval Supplement (PAS) versus an original ANDA, Commander Fung replied that the filing review process is the same and that the agency examines the submission "as if it was originally an... original submission." He emphasized that applicants choosing a different method or approach should document and justify that approach in the submission modules cited.
