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U.S. Department of Health and Human Services

Drugs

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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.

NAME DEFINITION FDA CODE
FUNGAL CELL, NON-YEAST Literal FNG
INSECT CELL Literal INS
MAMMALIAN CELL Literal MAM
PLANT CELL Literal PLT
FUNGAL CELL, YEAST Literal YST