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Overhaul To Improve US OTC Monograph Program Could Steer Sponsors To NDA Process

 
• By Malcolm Spicer

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 Absence of assurance in draft guidance of confidentiality for information sponsors share with FDA before submitting OMORs also could influence some to choose NDA process.

• Source: Shutterstock

The US drug industry may need to lower its expectations about the number and variety of additional OTC drug formulations and indications becoming available in the US through the Food and Drug Administration’s overhauled monograph program.

Food and drug attorneys pointed out during a recent Food and Drug Law Institute online conference that even with the program becoming more efficient and predictable under reform authorized by...

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Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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More from Policy & Regulation

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

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EU Parliament Calls For Review Of Wastewater Directive’s Impact On Pharma Sector

 
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