FDA Tablet Scoring Guidance Advises Testing Patient Ability To Split Pills
Executive Summary
One of the intriguing elements of FDA’s draft guidance on tablet scoring is how it handles the relationship between brand and generic versions of the products.
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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.
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.
FDA’s Tablet Scoring Final Guidance Requires Generics To Be Same As Brand
Generic industry concerns that scoring conventions could create barriers to entry did not win out in final tablet scoring guidance; FDA says to contact it if the scoring convention is patent protected.