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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-GEN-10307
Data Element Name. INVAS Volume Type
Description. INVAS Volume Type describes the major categories of submissions received by the Center from sponsors and applicants.
Source.
Relationship.
FDA Specifications. No specifications.
CDER Specifications. INVAS Volume Type shall consist of a descriptive term with a maximum length of 60 alphanumeric characters, and code for those terms with a maximum length of 2 alphanumeric characters. The first character (i.e., D, I, or N) relates to a Drug Master File (DMF), Investigational New Drug Application (IND), or New Drug Application (NDA).
FDA Approved Date.
CDER Approved Date. February 1, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| DMF ORIGINAL PAPER COPY | Literal | DA |
| DMF DUPLICATE PAPER COPY | Literal | DB |
| DMF TAPE BACKUP OF ELECTRONIC COPY FOR DIMS | Literal | DL |
| DMF TAPE BACKUP OF ELECTRONIC COPY FOR EDR | Literal | DR |
| DMF TEMPORARY JACKET | Literal | DT |
| DMF VIDEO | Literal | DV |
| DMF ORIGINAL ELECTRONIC COPY | Literal | DX |
| DMF DUPLICATE ELECTRONIC COPY | Literal | DZ |
| IND ARCHIVAL PAPER COPY | Literal | IA |
| IND CHEMIST PAPER COPY | Literal | IB |
| IND PHARMACOKINETICS PAPER COPY | Literal | IP |
| IND PHARMACOLOGIST PAPER COPY | Literal | IC |
| IND REVIEW DIVISION PAPER FILE | Literal | ID |
| IND STATISTICS PAPER COPY | Literal | IS |
| IND TAPE BACKUP OF ELECTRONIC COPY FOR DIMS | Literal | IL |
| IND TAPE BACKUP OF ELECTRONIC COPY FOR EDR | Literal | IR |
| IND TEMPORARY JACKET | Literal | IT |
| IND VIDEO | Literal | IV |
| IND MICROBIOLOGIST PAPER COPY | Literal | IW |
| IND ORIGINAL ELECTRONIC COPY | Literal | IX |
| IND DUPLICATE ELECTRONIC COPY | Literal | IZ |
| NDA/ANDA ARCHIVAL PAPER COPY | Literal | NA |
| NDA/ANDA CHEMIST PAPER COPY | Literal | NB |
| NDA/ANDA PHARMACOLOGIST PAPER COPY | Literal | NC |
| NDA/ANDA REVIEW DIVISION PAPER FILE | Literal | ND |
| NDA/ANDA FIELD PAPER COPY | Literal | NF |
| NDA/ANDA ORIGINAL PAPER COPY OF ANY MARKETING MATERIALS OTHER THAN FORM 2253 | Literal | NG |
| NDA/ANDA ORIGINAL PAPER COPY OF FORM 2253 | Literal | NH |
| NDA/ANDA ACTION PACKAGE | Literal | NK |
| NDA/ANDA TAPE BACKUP OF ELECTRONIC COPY FOR DIMS | Literal | NL |
| NDA/ANDA MEDICAL OFFICER PAPER COPY | Literal | NM |
| NDA/ANDA PHARMACOKINETICS PAPER COPY | Literal | NP |
| NDA/ANDA TAPE BACKUP OF ELECTRONIC COPY FOR EDR | Literal | NR |
| NDA/ANDA STATISTICS PAPER COPY | Literal | NS |
| NDA/ANDA TEMPORARY JACKET | Literal | NT |
| NDA/ANDA VIDEO | Literal | NV |
| NDA/ANDA MICROBIOLOGIST PAPER COPY | Literal | NW |
| NDA/ANDA ORIGINAL ELECTRONIC COPY | Literal | NX |
| NDA/ANDA DUPLICATE ELECTRONIC COPY | Literal | NZ |