Drugs

Biotechnology Origin

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00405

Version Number. 001

Data Element Name. Biotechnology Origin

Description. This standard provides for all major classifications of cells that are used to make drugs through biotechnology.

Source. CDER.

Relationship.

FDA Specifications. None.

CDER Specifications. Biotechnology Origin (abbreviated as BIOTECHNOLOGY_ORIGIN in the MIS reference table) shall consist of an alphabetic term which has a maximum length restricted to 240 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these terms shall consist of a maximum of three letters..

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

NAMEDEFINITIONFDA CODE
FUNGAL CELL, NON-YEASTLiteralFNG
INSECT CELLLiteralINS
MAMMALIAN CELLLiteralMAM
PLANT CELLLiteralPLT
FUNGAL CELL, YEASTLiteralYST

 

Page Last Updated: 12/12/2014
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