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DATA STANDARDS MANUAL |
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DATA STANDARDS MANUAL |
FDA Data Element Number.
CDER Data Element Number. C-DRG-00910
Version Number. 001
Data Element Name. Pediatric Exclusivity Study Basis
Description. Pediatric Exclusivity Study Basis describes the basis on which studies were done to support pediatric exclusivity claims.
Source.
Relationship.
FDA Specifications.
CDER Specifications. Pediatric Exclusivity Study Basis 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_BASIS).
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values. See next page.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| WRITTEN AGREEMENT PRESENT, STUDIES DONE ACCORDING TO WRITTEN AGREEMENT | Literal | 1 |
| WRITTEN AGREEMENT PRESENT, STUDIES NOT DONE ACCORDING TO WRITTEN AGREEMENT | Literal | 2 |
| WRITTEN AGREEMENT PRESENT, UNKNOWN IF STUDIES WERE DONE ACCORDING TO WRITTEN AGREEMENT | Literal | 3 |
| WRITTEN AGREEMENT NOT PRESENT, STUDIES DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES | Literal | 4 |
| WRITTEN AGREEMENT NOT PRESENT, STUDIES NOT DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES | Literal | 5 |
| WRITTEN AGREEMENT NOT PRESENT, UNKNOWN IF STUDIES WERE DONE ACCORDING TO GOOD SCIENTIFIC PRACTICES | Literal | 6 |