CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00905
Version Number. 001
Data Element Name. Pediatric Use Supplement PK/PD Category
Description. Pediatric Use Supplement PK/PD Category describes the pharmacokinetic and pharmacodynamic categories that are applicable to CDER Pediatric Use Supplements.
Source. 21CFR201.57 (f)(9).
Relationship.
FDA Specifications.
CDER Specifications. Pediatric Use Supplement PK/PD 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 |
---|---|---|
RAW DATA AND STUDY ANALYSIS | Literal | PR |
LITERATURE | Literal | PL |