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  6. Coordinator for Electronic Submissions of Individual Case Safety Reports
  1. FDA Adverse Event Monitoring System (AEMS)

Coordinator for Electronic Submissions of Individual Case Safety Reports

AEMS HelpDesk

Email: AEMSeSub@fda.hhs.gov

AEMS Esub Physical Media Submission Address for UPS and FedEx deliveries:

FDA / Central Document Room
Attn: [Please use one of the attention lines from below*]
5901-B Ammendale Rd
Beltsville, Md. 20705-1266

*Please use the following attention lines with this address, depending on what type of information you are sending. The attention line is extremely important because each type of package will be given a different priority for internal delivery depending on the type of report.

  • Attn: AEMS ICSR Reports Test
  • Attn: AEMS ICSR Reports Production
  • Attn: AEMS ICSR Reports Attachment Test
  • Attn: AEMS ICSR Reports Attachment Production
  • Attn: PSR/PSUR Test
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