CDER DATA STANDARDS MANUAL

FDA Data Element Number.

CDER Data Element Number. C-GEN-10306

Data Element Name. DFS RECOMMENDATION

Description. DFS RECOMMENDATION describes a recommendation that an individual reviewer makes in the course of a drug review, and which are entered into the electronic Division Files System (DFS). Some of these individual recommendations may collectively result in a similar final decision code for the particular submission.

Source. DFS Recommendation Code User Group.

Relationship.

FDA Specifications.

CDER Specifications. DFS RECOMMENDATION shall consist of an alphanumeric term which has a maximum length restricted to 60 characters, and a corresponding alphanumeric code with a maximum length of 2 characters.

FDA Approved Date.

CDER Approved Date.

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
APPROVABLE REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION COULD RESULT IN AN APPROVABLE DECISION AND AN OUTGOING LETTER. (DEFICIENCIES SUCH AS LABELING CHANGES MUST BE CORRECTED BEFORE APPROVAL.) AE
APPROVAL REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION COULD RESULT IN AN APPROVAL DECISION AND AN OUTGOING LETTER. AP
CLINICAL HOLD CLINICAL TRIALS SHOULD NOT BE STARTED, OR MUST BE PREMATURELY STOPPED. HO
DEFICIENCY REVIEW SHOWED SOME ABSENCE, EITHER OF FORMS OR DATA. (THIS CODE IS VALID FOR IND'S ONLY; USE EITHER AN AE OR NA CODE FOR NDA'S.) DE
DENIED REVIEW BY DESIGNATED CHEMIST DETERMINED THAT SUPPLEMENT DOES NOT QUALIFY AS SUPAC/CBE, OR THAT OTHER SPECIAL REQUEST (SUCH AS EXPEDITED REVIEW) SHOULD BE DENIED. USED ONLY ON SUPAC SPECIAL AMENDMENTS (SI, SS, SE, ST, OR SP) OR OTHER SPECIAL AMENDMENTS (E.G., AX). DN
FAX MINOR DEFICIENCY REVIEW DETERMINED THAT A SUBMISSION COULD REMAIN IN PENDING STATUS WHILE ALLOWING THE SPONSOR 30 DAYS TO RESPOND TO DEFICIENCIES FOR WHICH THE REVIEW OF THE RESPONSE IS EXPECTED TO TAKE LESS THAN ONE HOUR. USED ONLY FOR OGD CHEMISTRY ASSIGNMENTS. FD
FINAL MINUTES MINUTES OF DISCUSSION WERE AGREED TO AND WERE FOUND ACCEPTABLE BY ALL FDA ATTENDEES. (THIS CODE IS USED ONLY FOR IND MR DOCUMENTS). FM
GRANTED REVIEW BY DESIGNATED CHEMIST DETERMINED THAT SUPPLEMENT QUALIFIES AS SUPAC/CBE, OR THAT OTHER SPECIAL REQUEST (SUCH AS EXPEDITED REVIEW) MAY BE GRANTED. USED ONLY ON SUPAC SPECIAL AMENDMENTS (SI, SS, SE, ST, OR SP) OR OTHER SPECIAL AMENDMENTS (E.G., AX). GR
INFORMATION REQUEST A FORMAL REVIEW RESULTS IN AN INFORMATION REQUEST TO THE FIRM. THIS CODE IS ONLY TO BE USED FOR ANNUAL REPORTS, PERIODIC REPORTS, AND PHASE 4 RESULTS. THIS CODE SHOULD NEVER BE USED FOR IND'S, PENDING NDA'S, OR NDA SUPPLEMENTS. IR
NO CRITIQUE NECESSARY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION DID NOT WARRANT EITHER A FORMAL OR INFORMAL REVIEW. (FOR EXAMPLE, THIS CODE IS USED FOR SUBMISSIONS THAT REPORT A FIRM'S ADDRESS CHANGE, WHERE A REVIEWER DOES NOT NEED TO TAKE ANY FURTHER ACTION.) NC
NO DEFICIENCY A PARTICULAR DISCIPLINE DETERMINED THAT AN IND SUBMISSION HAD NO DEFICIENCIES. (THIS CODE SHOULD NEVER BE USED FOR NDA'S, WHICH SHOULD USE EITHER THE NR OR NC CODES.) ND
NO FORMAL REVIEW REQUIRED A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION WARRANTED AN INFORMAL REVIEW. (THIS CODE SHOULD BE USED FOR OCCURRENCES OF "REVIEW NOTED, NO COMMENTS" AND "REVIEW NOTED, WITH COMMENTS.") NR
NO LETTER NEEDED A FORMAL REVIEW WAS DONE, BUT THERE WERE NO COMMENTS THAT NEEDED TO BE CONVEYED TO THE FIRM, AND NO RECOMMENDATION. NL
NOT APPROVABLE REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION COULD RESULT IN A "NOT APPROVABLE" DECISION AND AN OUTGOING LETTER. NA
NOT APPROVABLE MINOR REVIEW DETERMINED THAT A SUBMISSION COULD RESULT IN A "NOT APPROVABLE MINOR" DECISION AND AN OUTGOING LETTER. USED ONLY FOR OGD CHEMISTRY ASSIGNMENTS. NM
PARTIAL CLINICAL HOLD REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION HAD A SPECIFIC CLINICAL PROTOCOL OR A SEGMENT OF A CLINICAL PROTOCOL THAT MAY NOT PROCEED. HP
REFUSAL TO FILE REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A SUBMISSION HAD MAJOR DEFICIENCIES, AND COULD RESULT IN A "REFUSAL TO FILE" LETTER. RF
REMOVE CLINICAL HOLD REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT A CLINICAL HOLD OR A PARTIAL CLINICAL HOLD COULD BE REMOVED. RH
SAFE TO PROCEED A 30 DAY IND SAFETY REVIEW OF THE INITIAL SUBMISSION HAS NOT RESULTED IN THE NEED FOR EITHER A PARTIAL OR FULL CLINICAL HOLD, AND THEREFORE CLINICAL TRIALS ARE SAFE TO PROCEED. SA
SUPAC INCORRECT SUBMISSION REVIEW BY DESIGNATED CHEMIST DETERMINED THAT SUPPLEMENT WAS INCORRECTLY SUBMITTED AS SUPAC. USED ONLY ON SUPAC SPECIAL AMENDMENTS (SI, SS, SE, ST, OR SP). IS
SUPAC PRIOR APPROVAL SUPPLEMENT WAS SUBMITTED AS PRIOR APPROVAL SUPAC AND NO GRANTED/ DENIED EVALUATION IS REQUIRED. USED ONLY ON SUPAC SPECIAL AMENDMENTS (SI, SS, SE, ST, OR SP). PL
SUPPLEMENT REQUEST REVIEW BY A PARTICULAR DISCIPLINE DETERMINED THAT INFORMATION SHOULD BE SUBMITTED AS A SUPPLEMENT. USUALLY USED FOR ANNUAL REPORTS. USED BY OGD ONLY. SR

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