FDA finalizes safety reporting guidances for sponsors and investigators

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies. Both guidances were issued on 16 December.

The guidance for clinical investigators aims to assist them in meeting the safety reporting requirements for investigational new drug (IND) studies and investigational new device exemption (IDE) studies. The guidance finalizes a draft version issued on 30 September 2021 (RELATED: FDA drafts safety reporting guidance for drug and device investigators, Regulatory Focus, 1 October 2021).

Revisions from the 2021 previous guidance include new information about investigator reporting to sponsors for IND studies, such as the timing for reporting serious adverse events.

The guidance is intended to help investigators identify serious adverse events (SAEs) that must be immediately reported to the sponsor. It also identifies the safety information that is considered an unanticipated problem involving risk to human participants requiring prompt reporting to institutional review boards (IRBs).

The guidance also addresses investigator review of IND safety reports received from sponsors. “The investigator should review all IND safety reports received from sponsors as a part of the investigator’s responsibility to protect the rights, safety, and welfare of trial participants (see § 312.60),” according to the guidance. “The investigator should similarly review all reports of safety information from IND-exempt [bioavailability/bioequivalence (BA/BE)] studies.”

The FDA views the evaluation of these reports as essential for fulfilling the investigator’s duty to safeguard the rights, safety, and welfare of the participants in their care.

FDA also finalized guidance to assist sponsors in meeting the expedited safety reporting requirements for human drugs and biological products being investigated under an IND application or as part of a (BA/BE) study.

The guidance finalizes the draft issued in June 2021 (RELATED: FDA releases new draft guidance on sponsor role for safety reporting requirements, Regulatory Focus, 25 June 2021).

“Changes from the draft to the final guidance include revisions to the recommended approaches for aggregate analyses to reduce the need for unblinding to evaluate safety data; additional considerations for small programs and rare diseases; updated information for electronic submission of IND safety reports; and editorial changes for clarity,” FDA explained in a Federal Register notice.

The guidance includes updated recommendations for the planned unblinding of safety data and its impact on the integrity of trials. It also provides greater flexibility regarding which party can review aggregate safety information for IND safety reporting. Additionally, the guidance clarifies the scope and methodology of aggregate analyses and outlines the components that should be included in a safety surveillance plan.

The guidance provides an overview of IND safety reporting requirements. It addresses how sponsors must report in an IND safety report any suspected adverse reaction to the study treatment that is both serious and unexpected.

“The sponsor must report in an IND safety report any suspected adverse reaction to the study treatment that is both serious and unexpected…..Before submitting an IND safety report, the sponsor needs to ensure that the event meets three criteria: (1) it is serious; (2) it is unexpected (i.e., is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed) or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan; and (3) there is evidence to suggest a causal relationship between the drug and the adverse event (i.e., it is a suspected adverse reaction),” according to FDA.

Final guidance on safety reporting; FDA final guidance on safety reporting of BE studies

FDA finalizes safety reporting guidances for sponsors and investigators

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