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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-00920
Version Number. 001
Data Element Name. PACT Fulfillment Category
Description. This standard provides for all PACT study fulfillment categories. PACT studies are post-marketing studies for the Office of Generic Drug Products that are imposed upon a pharmaceutical firm as a condition for drug approval. Defining the various fulfillment categories for each study will permit CDER management to determine trend analysis.
Source. Office of Generic Drug Products
Relationship. PACT Commitment Category
FDA Specifications. None.
CDER Specifications. PACT Category shall consist of an alphabetic term which has a maximum length restricted to 100 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these PACT Fulfillment Categories shall consist of two digits separated by a decimal.
FDA Approved Date. None.
CDER Approved Date. January 21, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| DEFINITION | NAME | FDA CODE |
|---|---|---|
| Study Not Begun, Will Begin in Future | Literal | 1.1 |
| Study Not Begun, Company Did Not Agree to Conduct Study | Literal | 1.2 |
| Study in Progress, Underway | Literal | 2.1 |
| Report of Study Submitted, Deemed Adequate by FDA | Literal | 3.1 |
| Report of Study Submitted, Deemed Inadequate by FDA | Literal | 3.2 |
| Report of Study Submitted, No Adequacy Determination by FDA | Literal | 3.3 |