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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-00918
Version Number. 001
Data Element Name. Industry Meeting Response
Description. Industry Meeting Response describes the various responses that CDER can make to formal industry meetings.
Source. FDA Modernization Act of 1997
Relationship. Industry Meeting Type describes the types of industry meetings to which a response can occur.
FDA Specifications. None.
CDER Specifications. Industry Meeting Response shall consist of an alphanumeric term which has a maximum length restricted to 14 characters, and a corresponding alphabetic code with a maximum length of 1 characters. (Reference table column_id = fda_response). The word "package" in the definition refers to materials that the firm was required to submit prior to a cut-off date for review or consideration.
FDA Approved Date.
CDER Approved Date. December 14, 1998
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| CANCEL-LATE PACKAGE | The meeting was canceled by CDER because the package from the firm was received late. | L |
| CANCEL-OTHER | The meeting was canceled by CDER for a reason other than the package from the firm being received late. | O |
| DENIED | The request for a meeting was denied by CDER. | D |
| GRANTED | The request for a meeting was granted by CDER. | G |
| WITHDRAWN | The request for a meeting was withdrawn by the firm. | W |