DATA STANDARDS MANUAL |
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 |