OTC Monograph Purity Concern Among Problems Noted In US FDA FY21 Drug Quality Review
Data Point To More Recalls As Inspections Increase, Problems With Firms' Investigations
Manufacturing sites drew high marks in FY21, especially for essential medicines and complex drugs. But inspection resumption means more recalls are coming, and inspection protocols indicate problems with investigations. Meanwhile, site data suggest post-pandemic supply chain is growing even more dispersed, particularly for essential medicines, despite government onshoring initiatives.
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Some would-be sponsors might opt against submitting OMORs because NDA process could offer more room for adjustments and a better chance for success. Absence of assurance in draft guidance of confidentiality for information sponsors share with FDA before submitting OMORs also could influence some to choose NDA process.
Recent draft guidance on scheduling FDA meetings to discuss potential OTC monograph order requests marks step in program overhaul authorized in 2020 legislation, but isn’t a signal for manufacturers, other industry stakeholders to expect meetings soon.
Objections to 15 February reporting date established in draft guidance spurred rare last-minute notice assuring industry that it was a non-binding recommendation, not a requirement. Action reflects confusion that can arise in interpreting policy guidance.