Overhaul To Improve US OTC Monograph Program Could Steer Sponsors To NDA Process
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 Absence of assurance in draft guidance of confidentiality for information sponsors share with FDA before submitting OMORs also could influence some to choose NDA process.
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US FDA Catches Up On Monograph Petitions: Denies Antiseptic TFM Requests Made In 2001
Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
US Consumer Health Industry In 2023: Monograph Results, Switch Hopes On OTC Drug Sector Radar
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.
OTC Monograph Purity Concern Among Problems Noted In US FDA FY21 Drug Quality Review
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.