Drugs

Pediatric Use Supplement Safety/Adverse Reaction Category

FDA Data Element Number.

CDER Data Element Number. C-DRG-00906

Version Number. 001

Data Element Name. Pediatric Use Supplement Safety/Adverse Reaction Category

Description. Pediatric Use Supplement Safety/Adverse Reaction Category describes the safety and adverse reaction categories that are applicable to CDER Pediatric Use Supplements.

Source.

Relationship.

FDA Specifications.

CDER Specifications. Pediatric Use Supplement Safety/Adverse Reaction 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.

NAME DEFINITION FDA CODE
CLINICAL EFFICACY TRIALS, RAW DATA AND STUDY ANALYSIS Literal CR
CLINICAL EFFICACY TRIALS, LITERATURE Literal CL
ANECDOTAL REPORTS, MEDWATCH / FORM 3500 Literal AM
ANECDOTAL REPORTS, LITERATURE Literal AL

 

Page Last Updated: 12/10/2014
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