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U.S. Department of Health and Human Services

Drugs

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Phase 4 Fulfillment Category

FDA Data Element Number. None.

CDER Data Element Number. C-DRG-00902

Data Element Name. Phase 4 Fulfillment Category

Description. This standard provides for all Phase 4 study fulfillment categories. Phase 4 studies are post-marketing studies 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. DHHS Office of Inspector General, "Postmarketing Studies of Prescription Drugs" dated November 1995.

Relationship. Phase 4 Commitment Category

FDA Specifications. None.

CDER Specifications. Phase 4 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 Phase 4 Fulfillment Categories shall consist of two digits separated by a decimal.

FDA Approved Date. None.

CDER Approved Date. February 13, 1996.

FDA Revised Date.

CDER Revised Date. April 21, 1997.

Data Values.

NAME DEFINITION 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 Not Begun, Company Awaiting Approval of Supplement Literal 1.3
Study in Progress, Underway Literal 2.1
Study in Progress, Report In Preparation Literal 2.2
Study in Progress, Halted Literal 2.3
Study in Progress, Perpetual Literal 2.4
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
Company Released from Commitment, Drug Not Marketed Literal 4.1
Company Released from Commitment, Question Answered by Other Studies Literal 4.2
Company Released from Commitment, Reason Unclear Literal 4.3
Company Released from Commitment, Study Not Feasible Literal 4.4
Company Released from Commitment, Study Fulfilled Literal 4.5
Status Unknown, No Information Literal 5.1