FDA shifts IND safety reporting over to FAERS in finalized guidance

The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events to FDA’s Adverse Event Reporting System (FAERS). Currently, these reports are submitted in electronic common technical document (eCTD) format using PDF files.

FDA called the current practice “inefficient and labor intensive” to review and track. These reports are submitted to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

FDA added that it will accept the IND safety reports submitted to FAERS before the effective date.

This guidance finalizes a draft guidance issued in October 2019. (RELATED: FDA to Require Certain IND Safety Reports to be Submitted to FAERS, Regulatory Focus 29 October 2019)

The guidance contains a few revisions from the draft. Such changes include the incorporation of an updated technical conformance guide called the “Electronic Submission of IND Safety Reports Technical Conformance Guide” as well as the updated FDA regional implementation guide for E2B(R3) for electronically transmitting individual case safety reports for drugs and biological products. Both were issued in 2022.

Another change specifies that certain bioavailability (BA) and bioequivalence (BE) studies conducted under an IND will be subject to the new safety reporting requirements.

The guidance specifies that sponsors must report any suspected adverse reaction associated with an investigational drug if it is both serious and unexpected and “if there is evidence to suggest a causal relationship between the drug and the adverse event.”

The guidance covers the specifications for submitting IND safety reports to FAERS, resubmission considerations, and how the agency will address waivers for reporting safety information.

The Pharmaceutical Research and Manufacturers of America (PhRMA), in its comments on the 2019 draft, expressed its support for FDA’s “judicious” timeline of allowing a two-year implementation period.

FDA did not did not adopt a suggestions by TransCelerate BioPharma Inc. to accept simultaneous, or parallel submission of both the traditional IND safety reports and the FAERS during the two year interim before the new reporting requirements take effect.

The agency also rejected TransCelerate’s suggestion to include a section in the final guidance addressing expectations and recommendations for cross-reporting safety information for a product that is used to treat multiple indications.

Guidance

FDA shifts IND safety reporting over to FAERS in finalized guidance

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