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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
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 |