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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 Absence of assurance in draft guidance of confidentiality for information sponsors share with FDA before submitting OMORs also could influence some to choose NDA process.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 Congress, firms will need to invest in research and studies to support proposals for monograph additions or changes and pay user

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More from Policy & Regulation

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
• By Eileen Francis and Lauren Nardella

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Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”