Can I respond to an FDA Request for Additional Information electronically?
Yes. Responses to FDA’s Request for Additional Information can be reported under MedWatch 3500A, Section H10. This includes all discrete data elements. Note that this is different from how supplemental reports are submitted (refer to question above). You may submit the letter you received as part of the attachment to the message. Make sure you denote the report as a follow-up in Section G7, and provide a follow-up number. Indicate the follow-up is due to a Response to FDA Request in Section H2.
