Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of real world data not currently reflected in the Data Standards Catalogue, according to industry comments on the agency’s draft guidance.
Overall, comments from industry generally supported the principles in FDA’s draft guidance on data standards for drug and biological products submissions containing real world data (RELATED: FDA drafts data standards guidance for RWD, Regulatory Focus, 22 October 2021). The guidance addresses considerations for using data standards currently supported by the FDA in applicable drug submissions containing data from real world data sources.
