Comment from Sumiya Mushtaq
AnonymousSupportIndividual
Summary: Sumiya Mushtaq, a regulatory affairs professional and pharmacist, supports the workshop's goals by recommending specific research priorities to improve generic drug approval efficiency. The commenter argues that the FDA should focus on research that helps applicants prevent submission-stage deficiencies, such as improving CMC completeness, applying ICH Q12 standards to original submissions, and developing applicant-side AI/ML tools.
Please see the attached PDF for my full public comment.
In brief: I am a regulatory affairs professional (PharmD) offering input on GDUFA science and research priorities from an applicant-side, dossier-preparation perspective, informed by attending the FY 2026 Generic Drug Science and Research Initiatives Public Workshop. I recommend that FDA prioritize research on:
The preventable, submission-stage drivers of multi-cycle ANDA assessment (CTD Module 3 / CMC completeness, pre-approval inspection data integrity, pharmacovigilance planning, and cross-functional coordination).
Extending ICH Q12 and Established Conditions discipline to original-submission quality, not only post-approval lifecycle management.
Applicant-side AI/ML tools that prevent deficiencies before submission, complementing assessment-side automation.
Operationalizing the "leveraging generic-drug industry expertise" theme to include submission-quality knowledge transfer from ICH-harmonized markets.
Continued product-specific guidance expansion paired with early-stage applicant guidance on CMC and bioequivalence.
Full detail is provided in the attached document.
Respectfully submitted,
Sumiya Mushtaq, PharmD, MBA