• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Pediatric Use Supplement PK/PD Category

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