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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA Releases Version 4.1 of OND Custom Medical Queries
The U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) has released version 4.1 of the OND Custom Medical Queries (OCMQs), which includes terms released in MedDRA v27.0 and earlier. OCMQ version 4.1 includes several minor updates to adverse event terms based on user feedback and committee review. OCMQs are intended to capture clinically meaningful groupings (i.e., safety signals) in premarketing safety data. OCMQs have become an important component of premarket drug safety evaluations, as they promote a consistent safety signal detection strategy across OND Divisions.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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