Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

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.

An individual consumer who has experienced inconsistent effects from different generic manufacturers argues that the FDA should fund research into independent batch testing of prescription medications. They contend that the current manufacturer-provided data and risk-based inspection models are insufficient for ensuring the quality and bioequivalency of generic drugs.

Mitchell Berger, submitting in a personal capacity, suggests that the FDA include a pediatric track, discuss the use of real-world data for post-market monitoring, and involve more diverse stakeholders like other government agencies and patient panels in the workshop. He argues that these additions would improve collaboration and address specific needs such as pediatric drug shortages and off-label use.