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OTC Monograph Application Reviews Get Deadlines, Not GRASE Flexibility

 
• By Malcolm Spicer

Changes to FDA's interpretation of the GRASE standard it uses to evaluate ingredient proposals would go further to opening the US monograph process to innovation and progress than setting deadlines for the reviews, industry stakeholders say.

Setting deadlines for FDA reviews of time and extent applications to add ingredients or indications to OTC monographs doesn't solve the problem that industry stakeholders say has crippled the monograph process.

Stakeholders say changes to FDA's interpretation of the generally recognized as safe and effective standard it uses to evaluate ingredient proposals would go further to opening the monograph process, or...

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