FDA’s Office of New Drugs outlines Custom Medical Queries, releases OCMQ v4.0 and MAP 6025.8

Linda Jiang, acting lead of the Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs, outlined the purpose, development and use of Office of New Drugs Custom Medical Queries (OCMQs) during a Small Business Industry Assistance webinar.

Jiang said OCMQs are "standard groupings of related adverse event terms intended to assist with the identification of potential safety signals during the review of adverse event safety data." She emphasized the queries are tailored for pre‑market safety evaluation and do not replace review of individually reported adverse-event terms.

OCMQs group related MedDRA Preferred Terms that can otherwise split safety signals. "MedDRA PTs are highly granular," Jiang said, noting more than 25,000 PTs exist and that related events may be coded to different PTs (for example, abdominal pain may be recorded using several distinct PTs). She said OCMQs cast a wider net so related terms are considered together in OND safety analyses.

The office announced that OCMQ version 4.0 was released on April 29, 2026 and that there are currently 104 OCMQs covering concepts from common reactions such as headache and nausea to serious conditions including heart failure and liver injury. Jiang said OCMQ v4.1 contains minor updates based on user feedback and committee review and that OND anticipates annual updates tied to MedDRA releases, subject to agency resource availability.

Jiang described a three‑phase development process involving more than 80 FDA clinical reviewers: natural language processing of more than 38,000 drug labels to identify frequent adverse reactions, collaboration with OND review divisions and subject matter experts, and development of algorithmic OCMQs that leverage multiple data sources. "We needed a consistent approach to identify common safety signals from existing labels to standardize signal detection in marketing application review," she said.

OCMQ terms are organized into "narrow" and "broad" categories. Narrow terms prioritize specificity and indicate the OCMQ has occurred with a high level of confidence; broad terms are more sensitive and are "reasonably suggestive" of occurrence. Jiang reiterated that medical and regulatory judgment should guide whether to include specific PTs, the OCMQ name, or both in product labeling when a signal is identified.

OND has developed four algorithmic OCMQs — for drug‑induced muscle injury, hypoglycemia, hyperglycemia and hypersensitivity — that combine adverse‑event terms with laboratory values, medical history or timing criteria. As an example, for the drug‑induced muscle‑injury algorithm, inclusion can be based on a narrow OCMQ muscle‑injury term, abnormal urine myoglobin, CPK greater than five times the upper limit of normal without abnormal baseline CPK, a CPK‑MB/CPK ratio greater than 0.05 with a start date within three days, or clinical findings such as myalgia with muscular weakness or myoglobinuria/chromaturia occurring within seven days.

Jiang pointed attendees to MAP 6025.8, "Good Review Practices OND Custom Medical Queries," which the office released to define purpose, background, policy, responsibilities and procedures for OCMQs. She said the MAP and attached materials standardize how OCMQs are maintained, documented and integrated into OND safety-review outputs for new molecular entity NDAs, original 351(a) BLAs and relevant supplements. The MAP also makes clear that applicants are not required to use OCMQs; use by applicants is voluntary.

A public FDA webpage will host the current and prior OCMQ versions and a change log for transparency; Jiang provided a team email (OND biomedical informatics @fda.hhs.gov) for questions. She closed by summarizing the key takeaways: OCMQs support detection of safety signals through standardized, clinically meaningful groupings; they complement but do not replace individual adverse‑event review; and reviewers retain discretion to customize analyses.

The office said OCMQs will be updated following MedDRA releases and that updates depend on agency resources. The webpage with downloads and the MAP includes the full listings and change history.