FDA to Require Certain IND Safety Reports be Submitted to FAERS
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance requiring sponsors to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events to the FDA Adverse Event Reporting System (FAERS) starting 24 months after the guidance is finalized.Currently, such reports are submitted to FDA in electronic common technical document (eCTD) format using PDF files, which FDA says are “inefficient and labor intensive” to review and track.
“Submission of this important safety information to FAERS as structured data elements will improve FDA’s ability to review and track these potential safety signals that occur during the conduct of clinical trials, and will provide sponsors with a reporting format that is consistent with International Council for Harmonisation (ICH) guidelines and reporting requirements to other regulatory agencies,” FDA writes.
The switch to submitting IND safety reports for serious and unexpected suspected adverse events is part of FDA’s effort to implement the electronic submission requirements of Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.
While federal agencies are not typically able to establish new requirements via guidance, Congress gave FDA explicit authorization to do so to establish the format for electronic submissions under Section 745A(a).
For now, FDA says sponsors will be able to continue submitting such IND safety reports via eCTD, though sponsors may voluntarily submit the reports to FAERS before the requirement is in effect.
Once effective, the guidance will supersede FDA’s final guidance Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications for IND safety reports that fall within the scope of the new guidance.
Under the policy laid out in the guidance, sponsors must submit IND safety reports to FAERS via FDA’s Electronic Submission Gateway (ESG) or Safety Reporting Portal (SRP).
FDA notes that the guidance does not apply to IND safety reports for anything other than serious and unexpected suspected adverse events, such as reports detailing findings from other studies, findings from animal or in vitro testing or of increased rate of occurrence of serious suspected adverse reactions.
Additionally, FDA says that submissions for noncommercial INDs will be exempt from the electronic submission requirements under Section 745A(a), though the agency encourages such sponsors to do so.
Alongside the draft guidance, FDA issued a separate technical conformance guide meant to supplement the draft guidance by detailing the format that should be used for IND safety reports submitted to FAERS as individual case safety reports (ICSRs) and IND safety reports that should be submitted to FDA in electronic common technical document (eCTD) format.
FDA