for the official memorandum describing FDA's readiness
to accept these reports electronically in lieu of paper. This table shows which safety reports and formats FDA is currently able
to accept in electronic format instead of paper. See FDA
Docket 92S-0251 for the official memorandum describing FDA's readiness
to accept these reports electronically in lieu of paper.
|
Type of Submission |
Format |
Status |
|---|---|---|
| Individual Case Safety Reports (ICSRs) without attachments - Expedited (15-day) and Periodic | E2B/M2 DTD Version 2.0 | Accepting these reports electronically through FDA's ESTRI Gateway or on physical media. |
| ICSRs without attachments - Expedited (15-day) and Periodic | E2BM / M2 DTD Version 2.1 | Accepting these reports electronically through FDA's ESTRI Gateway or on physical media. |
| Attachments to ICSRs | Accepting these submissions on physical media.* FDA is planning to also accept these submissions through the FDA's ESTRI Gateway but has not yet determined when this capability will be available. | |
| Periodic reports - Descriptive information | Not yet accepting these submissions in an electronic format. FDA expects to accept these submissions electronically in the near future. |
*If an ICSR includes an attachment, you may submit the ICSR and its attachment in an electronic format (i.e., ICSRs may be submitted through the ESTRI Gateway or on physical media; the attachment needs to be submitted on physical media) or submit the ICSR and its attachment on paper. Do not mix paper and electronic submissions for ICSRs. For example, you should not submit the ICSR electronically and submit its attachment on paper.
Last updated: January 17, 2006