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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00911
Version Number. 001
Data Element Name. Pediatric Exclusivity Study Drug List
Description. Pediatric Exclusivity Study Drug List describes whether a drug is marketed, and if so, whether it already appears on the Pediatric Exclusivity List.
Source.
Relationship.
FDA Specifications.
CDER Specifications. Pediatric Exclusivity Study Drug List shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding numeric code with a maximum length of 3 characters. (Reference table column_id = PED_EX_STUDY_DRUG_LIST).
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| DRUG ALREADY MARKETED, ON THE LIST | Literal | 1 |
| DRUG ALREADY MARKETED, NOT ON THE LIST | Literal | 2 |
| DRUG NOT MARKETED | Literal | 3 |