How to provide IND Safety Reports to FDA

A new FDA guidance describes the electronic format sponsors will be required to use when they electronically submit investigational new drug application (IND) safety reports to the agency. The guidance finalizes the draft guidance of the same name published in October 2019.

Scope of the guidance

Sponsors of INDs are required to submit IND safety reports electronically in the format specified in the guidance unless the sponsor is exempted from the electronic submission requirements or a waiver is obtained.

The guidance applies only to IND safety reports for serious and unexpected suspected adverse reactions (SUSARs), which includes both 7- and 15-day reporting requirements depending on the severity of the event. Submission of this safety information to the FDA Adverse Event Reporting System (FAERS) as structured data elements will improve the agency’s ability to review and track potential safety signals that occur during the conduct of clinical trials and will provide sponsors with a reporting format that is consistent with ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) and reporting requirements to other regulatory agencies.

Sponsors must report any suspected adverse reaction that is both serious and unexpected if there is evidence to suggest a causal relationship between the drug and the adverse event, such as in the following circumstances:

  • A single occurrence of an adverse event that is uncommon and known to be strongly associated with drug exposure (e.g., angioedema, hepatic injury, Stevens-Johnson syndrome) 
  • One or more occurrences of an adverse event that is not commonly associated with drug exposure but is otherwise uncommon in the population exposed to the drug (e.g., tendon rupture)
  • An aggregate analysis of specific adverse events observed in a clinical trial (e.g., known consequences of the underlying disease or condition under investigation, other adverse events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group

For more information please see FDA's guidance Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry.

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