Overview

The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.

Introduction

The Food and Drug Administration (FDA or Agency) is informing the public about a draft guidance document. This guidance’s availability will be announced in the Federal Register on April 1, 2026. Until the specified requirements become effective, sponsors who electronically submit Investigational New Drug (IND) safety reports concerning serious and unexpected suspected adverse reactions must follow the latest effective version of the electronic Common Technical Document (eCTD) guidance. Before the outlined requirements take effect, the FDA will accept IND safety reports submitted to the FDA Adverse Event Reporting System (FAERS) under a voluntary submission program. During this voluntary submission period, sponsors who choose to submit IND safety reports to FAERS should refrain from submitting them in eCTD format. For more information on this voluntary submission process, please consult the FAERS Electronic Submissions webpage.

The recommendations:

  • Upon the implementation of these recommendations, sponsors electronically submitting Investigational New Drug (IND) safety reports for serious and unexpected suspected adverse reactions should continue to adhere to the most recent effective version of the electronic Common Technical Document (eCTD) guidance.
  • Prior to the effective date of the outlined requirements, the FDA will facilitate the acceptance of IND safety reports to the FDA Adverse Event Reporting System (FAERS) as part of a voluntary submission program.
  • During this voluntary submission program, sponsors opting to submit IND safety reports to FAERS should cease submitting those reports in eCTD format.

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References

Learn more about FDA. For the link, click here

Submissions in Electronic Format

U.S. FOOD & DRUG ADMINSTRATION

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