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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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 Advises Medication Error Risk Assessment Early In Development
FDA’s draft guidance on safety considerations for product and container design to minimize medication errors calls for assessments in “real world” settings early in the development process. Relying solely on clinical trials is inadequate for a number of factors the agency and sponsors need to know about a new drug product, the draft says.