Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies

Regulatory NewsRegulatory News | 02 August 2022 |  By 

The US Food and Drug Administration (FDA) has issued draft guidance providing instructions for how generic drug manufacturers can electronically submit expedited individual case safety reports (ICSRs) for serious adverse events through the FDA Adverse Event Reporting System (FAERS).

The draft guidance, issued on 02 August, applies to investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies. Expedited safety reports for IND-exempt BA/BE studies have been submitted directly to the Office of Generic Drugs by email, phone, or fax using Form FDA 3500A, but enhancements to the FAERS – once activated -- will allow these reports to be submitted electronically to that system.

FDA is not currently accepting submission of premarket ICSRs through the FAERS, but the guidance is aimed at helping generic sponsors prepare their systems. In the meantime, sponsors should continue to submit electronic safety reports to the Office of Generic Drugs. The FAERS electronic submissions website will have updates on the system’s readiness and the latest guidance.

Once the enhancements are activated, sponsors can choose to submit ICSRs and attachments, which provide supporting information, to FAERS either through database-to-database transmission or though the safety reporting portal (SRP).

Sponsors with database-to-database transmission capability can submit ICSRs in XML format through the Electronic Submission Gateway (ESG). Once the information is received through the ESG, the ICSRs will be processed into the FAERS database. If choosing this submission method, FDA recommends referring to the technical specifications document with instructions for organizing and preparing ICSR and ICSR attachments, finalized in April 2022.

Sponsors who do not have database-to-database transmission capability can manually enter the ICSR information into a web-based form on the SRP.

To submit reports via either method, the submitter needs to have an account with FDA and separate accounts are needed for database-to-database and SRP submission. Contact the FAERS electronic submissions coordinator at faersesub@fda.hhs.gov to create an account.

In the draft guidance, FDA recommended that the submitter create a unique case identification number for each ICSR to be used for the initial report and any follow up reports. Additionally, attachments that are submitted with the initial ICSR should not be resubmitted with a follow up report and follow up ICSRs should only be submitted electronically if that is how the initial ICSR was submitted.

FDA also recommended that sponsors unblind exposures to study drugs for subjects who experience a serious adverse event before submission of the ICSR. Knowledge of the treatments may be necessary to interpret the adverse event, for medical management, and to provide safety information on the drug and have implications for the conduct of the ongoing study, according to the draft guidance. “FDA does not believe that unblinding single or small numbers of [serious adverse event] cases will compromise the integrity of the study, in part because such ‘unblinding’ should be infrequent,” according to the draft guidance.

Stakeholders can comment on the draft version of the guidance until 03 October 2022 on www.regulations.gov under docket no. FDA-2022-D-0528.

Draft guidance


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