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  1. Policies/Guidance

Center Submission Types

Center Submission Type (PDF)

 

      Web Trader AS2
Center Submission Types (*not for general public)  Routing ID Test Prod Test Prod
CBER 510K CBER_510K Yes Yes Yes Yes
AERS FDA_AERS Yes Yes Yes Yes
AERS_Attachments FDA_AERS_ATTACHMENTS Yes Yes Yes Yes
CDISC CBER_CDISC Yes Yes Yes Yes
EBLA CBER_EBLA Yes Yes Yes Yes
eDMF CBER_EDMF Yes Yes Yes Yes
EIDE CBER_EIDE Yes Yes Yes Yes
EIND CBER_EIND Yes Yes Yes Yes
EUA CBER_EUA Yes Yes Yes Yes
Lot_Release_Protocol CBER_LOT_RELEASE_PROTOCOL Yes Yes Yes Yes
NDA CBER_NDA Yes Yes Yes Yes
PRE_IND CBER_PRE_IND Yes Yes Yes Yes
Promotional_Materials CBER_PROMOTIONAL_MATERIAL  Yes Yes Yes Yes
PMA CBER_PMA Yes Yes Yes Yes
QSUBS CBER_QSUBS Yes Yes Yes Yes
SEND_PILOT CBER_SEND_PILOT Yes No Yes No
SPL_LDD CBER_SPLLD Yes Yes Yes Yes
VAERS CBER_VAERS Yes Yes Yes Yes
CDER ACA6004_Drug_Samples CDER_ACA6004 Yes Yes Yes Yes
AERS FDA_AERS Yes Yes Yes Yes
AERS_Attachments FDA_AERS_ATTACHMENTS Yes Yes Yes Yes
AERS IND AERS_IND Yes No Yes No
AERS Attachment IND AERS_ATTACHMENTS_IND Yes No Yes No
AERS_PREMKT FDA_AERS_ PREMKT Yes No Yes No
AERS_Attachments_PREMKT FDA_AERS_ATTACHMENTS_ PREMKT Yes No Yes No
ECTD CDER_ECTD Yes Yes Yes Yes
EIND CDER_EIND Yes Yes Yes Yes
GDUFA_Facility_Registration CDER_GDUFA_FACILITY_REGISTRATION Yes Yes Yes Yes
PFC CDER_PFC Yes Yes Yes Yes
Voluntary_Direct_AEs WebTrader Submission ONLY Yes Yes No No
CDRH Adverse_Events CDRH_AERS Yes Yes Yes Yes
Electronic_Submissions CDRH_ESUBS Yes Yes Yes Yes
GUDID CDRH_GUDID Yes Yes Yes Yes
CFSAN Form 3480 CFSAN_FORM3480 Yes Yes Yes Yes
Form 3480A CFSAN_FORM3480A Yes Yes Yes Yes
Form 3503 CFSAN_FORM3503 Yes Yes Yes Yes
Form 3665 CFSAN_FORM3665 Yes Yes Yes Yes
Form 3666 CFSAN_FORM3666 Yes Yes Yes Yes
Form 3667 CFSAN_FORM3667 Yes Yes Yes Yes
Threshold_of_Regulation CFSAN_TRESHOLD_OF_REGULATION Yes Yes Yes Yes
NDI CFSAN_NDI Yes Yes Yes Yes
EON_Payload_Files* CFSAN_EON_PAYLOAD_FILES Yes Yes Yes Yes
DSR_Adverse_Events CFSAN_DSR_ADVERSE_EVENTS No No Yes Yes
Food_Pilot_Listing CFSAN_FPL Yes Yes Yes Yes
CTP Electronic_Submission CTP_ESUB Yes Yes Yes Yes
Adverse_Events CTP_AE No No Yes Yes
CVM eSubmitter CVM_ESUBMITTER Yes Yes Yes Yes
Adverse_Events_Reports CVM_AERS Yes Yes Yes Yes
Electronic_Submissions CVM_ESUBS Yes Yes Yes Yes
MWP MWP_Report* MWP_REPORT No No Yes Yes
OC SPL OC_REGLIST_SPL Yes Yes Yes Yes
OOPD HUD_Designation_Requests OOPD_HUD_DESIGNATIONS Yes No Yes No
Orphan_drug_Resignation_Requests OOPD_ORPHAN_DRUG_DESIGNATIONS Yes No Yes No
OPQ 704a4_Pharma_Inspection_Records OPQ_704a4PIR Yes Yes No No
ORA Gamma_Rays_Analysis ORA_Gama_Rays_Analysis Yes No No No
GWTEST ConnectTest GWTEST_CONNECTION Yes No Yes No
SizeTest GWTEST_7GB Yes No Yes No
HC Transaction HC_Transaction Yes Yes Yes Yes

 

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