Center Submission Types
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 | |
BEST | CBER_BEST | 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 | |
FFU-PILOT | CDER_FFU-PILOT | Yes | No | Yes | No | |
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 | |
DSR_Adverse_Events | CFSAN_DSR_ADVERSE_EVENTS | No | No | 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 | |
CVM-VDD | eSubmitter (WebTrader: Electronic_Submissions) |
CVMVDD_eSubmitter | 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 | Inspection | ORA_Inspection | 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 |