GDUFA is the law that lets the FDA collect fees from generic drug makers to speed up approvals. Since 2012, it's cut review times, reduced backlogs, and kept affordable medicines flowing to patients.
Causes of Generic Drug Shortages: Manufacturing and Supply Chain Issues
Generic drug shortages are caused by manufacturing failures, global supply chain concentration, lack of backup capacity, and profit-driven market pressures. Over 95% of shortages involve generics, with most stemming from single-source production and low margins.