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Regulatory News In Brief

This article was originally published in The Tan Sheet

Executive Summary

FDA issues guidance on splitting tablets

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Generic and private label industry concerns that scoring conventions could create barriers to market entry did not win out in the agency’s final tablet scoring guidance. FDA advises firms to contact the agency when questions arise about a product’s scoring being patent-protected.

FDA Tablet Scoring Guidance Holds Brands, Generics To Single Standard

Generic and private label industry concerns that scoring conventions could create barriers to market entry did not win out in the agency’s final tablet scoring guidance. FDA advises firms to contact the agency when questions arise about a product’s scoring being patent-protected.

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