CDER DATA STANDARDS MANUAL

FDA Data Element Number.

CDER Data Element Number. C-DRG-00914

Version Number. 001

Data Element Name. Geriatric Use Supplement Clinical Efficacy Trials Category

Description. Geriatric Use Supplement Clinical Efficacy Trials Category describes the clinical efficacy trials categories that are applicable to CDER Geriatric Use Supplements.

Source. Form FDA 3437.

Relationship.

FDA Specifications.

CDER Specifications. Geriatric Use Supplement Clinical Efficacy Trials Category shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. (Reference table column_id = ger_use_sup_clin)

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

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