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.

Back to Data Standards