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Submission Types Accepted by FDA Centers |
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| CBER |
AERS - Adverse Event Reports AERS Attachments BLA - Biologics License Application (eCTD and eBLA format) eCTD - Electronic Common Technical Document IDE - Device Exemption IND - Investigational New Drug Application (eCTD and eIND format) DMF - Drug Master File Promotional Materials |
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CDER |
AERS - Adverse Event Reports AERS Attachments ANDA - Abbreviated New Drug Application BLA - Biologics License Application (eCTD and eBLA format) eCTD - Electronic Common Technical Document NDA - New Drug Application (eCTD and eNDA format) IND - Investigational New Drug Application |
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CDRH |
Adverse Events Electronic Submissions |
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CVM |
Electronic Submissions |
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