FDA finalizes electronic postmarketing safety reporting guidance

Regulatory NewsRegulatory News
| 27 April 2022 | By Ferdous Al-Faruque 

Source: Kampus Production/ Pexels

The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically. The guidance follows a final rule and corresponding draft guidance issued by the agency in 2014 to streamline the safety reporting process.
On 27 April FDA published the Providing Submissions in Electronic Format—Postmarketing Safety Reports final guidance. The draft version was published in 2014 and applies to a wide swath of products including those with new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLA), as well as certain combination products and compounded drugs.
The guidance notably does not apply to vaccines, certain blood products, combination products marketed under a device application, and certain cell and tissue products.
Specifically, the guidance lays out how Individual Case Safety Reports (ICSR) should be filed with FDA after a safety alert has been raised. The reports should include certain information such as when an adverse drug event happened, the name of the suspected medical product and the name of the person who initially reported the event.
Manufacturers can submit reports electronically in two ways to FDA Adverse Event Reporting System (FAERS) database. They can either submit ICSRs and ICSR attachments directly through the Electronic Submissions Gateway (ESG) or manually through the Safety Reporting Portal (SRP).
FDA says both options should be available to manufacturers 24 hours a day, 7 days a week. However, manufacturers should stay consistent and update ICSRs through the ESG if that’s how they initially submitted their report and do the same for reports submitted through SRP to avoid potentially duplicating reports and creating confusion.
However, before submitting any reports manufacturers need to create an account with FDA and notifying the FAERS Electronic Submission Coordinator of their intent by sending an email to faersesub@fda.hhs.gov.
“The FAERS Electronic Submission Coordinator will assist you in creating an account and ensuring that all steps have been completed for successful submission of postmarketing safety reports,” the guidance states.
FDA notes that safety reporting often involves submitting a series of reports consisting of initial and follow-up ICSRs, along with any associated attachments, over the life cycle of an individual case. Each ICSR however includes a unique identification number which needs to stay consistent for any updates or follow-up report so the agency can better track the case.
“The same unique case identification number must be used for an initial ICSR and any follow-up ICSRs even if there is a transfer of ownership of an application or unapproved drug product, to ensure that the follow-up ICSR can be matched with the initial submission,” the guidance adds.
The guidance goes into further details such as getting notified by FDA that the agency has received the report, what to do if the FAERS site is down, or if ESG or SRP are unresponsive. It also explains how to request a temporary waiver from reporting requirements, which the agency says will be considered in “rare circumstances,” such as widespread internet outages or malware attacks.


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