Drugs

FDA Details Standardized Approach to Drug Safety Signal Detection

A new CDER Office of New Drugs (OND) webinar discusses the development and use of OND Custom Medical Queries (OCMQs) to identify potential safety signals during review of clinical trial adverse event data in new molecular entity NDAs/BLAs and related supplements.

During the webinar, Biomedical Informatics and Regulatory Review Science acting associate director Linda Jeng described OCMQs as a key component of the agency's premarket drug safety review process, designed to improve the detection of adverse reactions that may be obscured by the highly granular coding structure of the Medical Dictionary for Regulatory Activities (MedDRA). She said the agency developed OCMQs to provide a consistent approach for identifying safety signals across drug reviews. "Related terms need to be consistently grouped together to ensure that important safety signals are identified," she said.

Zeng noted that a single clinical event may be coded under multiple MedDRA preferred terms, potentially making it more difficult to identify emerging safety concerns. OCMQs group related adverse event terms into clinically meaningful categories, allowing reviewers to evaluate broader medical concepts such as insomnia, hypersensitivity, heart failure, liver injury, and pancreatitis.

The current OCMQ version includes 104 medical queries covering both common adverse reactions and less frequent but medically significant events. FDA released Version 4.0 in April and recently updated the framework to Version 4.1.

According to the agency, the queries were developed through a multi-year effort involving more than 80 FDA clinical reviewers. The process included analysis of more than 38,000 drug labels spanning nearly six decades, consultation with subject matter experts, and development of algorithm-based queries that combine adverse event reports with laboratory values and other clinical data.

FDA has also published a new Manual of Policies and Procedures (MAPP) titled Good Review Practices: OND Custom Medical Queries, formalizing how the agency develops, maintains, and uses the queries.

Additionally, Zeng emphasized that the queries are intended to complement — not replace — traditional review methods, including analyses of individual adverse event terms and other safety groupings. The agency plans to update the OCMQs annually to reflect changes in MedDRA terminology and evolving regulatory experience.

Use of OCMQs by drug sponsors remains voluntary, she added.

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