CDER DATA STANDARDS MANUAL

FDA Data Element Number.

CDER Data Element Number. C-DRG-00904

Version Number. 001

Data Element Name. Pediatric Use Supplement Clinical Efficacy Trials Category

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

Source. Form FDA 3437.

Relationship.

FDA Specifications.

CDER Specifications. Pediatric 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.

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

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