CDER DATA STANDARDS MANUAL

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00601

Data Element Name. Indications.

Description. This standard provides for all drug indications.

Source. National Library of Medicine's Coach Metathesaurus Browser. This software is available in CDER through the LANMENU using Pathworks, and is located on the X drive. The Metathesaurus preserves the meanings, hierarchal connections, and other relationships between terms present in its source vocabularies, while adding certain basic information about each of its concepts and establishing new relationships between concepts and terms from different source vocabularies. In this way, it allows CDER to determine "best-fit" standardized indication terms for synonymous terms on different labeling (e.g., high blood pressure and hypertension; neoplasm and carcinoma).

Relationship.

FDA Specifications. None.

CDER Specifications. Standard drug indication terms shall consist of a maximum length restricted to 100 characters, with the accompanying code. International Classification of Diseases, Version 9, with Clinical Manifestations (ICD-9-CM) shall be the primary drug indication term, and Systemized Nomenclature of Medicine, Version III (SNOMED-III) shall be the secondary drug indication term. Both classification systems (ICD-9-CM and SNOMED-III) are necessary for those situations where a primary term is too broad (e.g., ICD-9-CM does not define specific microbial infections, while SNOMED-III does).

FDA Approved Date. None.

CDER Approved Date. May 10, 1994.

FDA Revised Date.

CDER Revised Date.

Data Values.

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