OTC Monographs Face Obsolescence In Shadow Of NDA Products
This article was originally published in The Tan Sheet
Executive Summary
Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.
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FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”
The agency will conduct a public hearing March 25-26 to garner input on improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.
FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”
The agency will conduct a public hearing March 25-26 for comments about improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.
FDA Floats OTC Monograph Overhaul To Be “More Agile And Responsive”
The agency will conduct a public hearing March 25-26 for comments about improving the OTC monograph process, which currently faces “significant challenges.” FDA’s proposals include expanding the process for allowing deviations from formulations approved through NDAs and issuing monographs by administrative order.