Adverse Event Reporting       

by | Jan 20, 2025 | Adverse Event, Complaints, Data, Enforcement Actions, FDA

When reporting an Adverse Event (AE) to the U.S. Food and Drug Administration (FDA), utilizing the FDA Adverse Event Reporting System (FAERS) is the most effective method. FAERS is a comprehensive database that includes adverse event reports, product quality complaints associated with adverse events, and reports related to medication errors (FDA, 2018). One of the key features of FAERS is that all submitted reports are publicly accessible, enabling transparency and enabling further analysis by researchers, healthcare professionals, and the public.

FAERS plays a critical role in identifying safety concerns associated with pharmaceutical products and assessing manufacturers’ compliance with regulatory standards. If a safety issue is identified through the data submitted to FAERS, the FDA conducts a more in-depth evaluation of the product involved. Depending on the severity of the findings, the FDA can take regulatory actions to ensure that the product remains safe and effective for public use. These actions are crucial for protecting public health and maintaining the integrity of the pharmaceutical market.

The FAERS system allows consumers, healthcare professionals, and manufacturers to submit reports. If a manufacturer receives an adverse event report from a consumer or healthcare provider, they are required to forward this report to the FDA for inclusion in the database. All submissions to FAERS are conducted electronically to streamline the process and ensure timely updates. However, it is important to note that FAERS data does have certain limitations. Factors such as the time a product has been on the market, the public visibility of the reported event, and whether the event is a recurring issue can influence the interpretation of the data.

The FAERS public dashboard provides users with access to all adverse event reports from 1968 to the present. Through this dashboard, users can easily view summaries of reports and search for information based on specific products and time periods. This feature is valuable for those conducting safety evaluations or researching potential concerns about particular products.

For those who need assistance with submitting adverse events or navigating the FAERS system, EMMA International is available to help. Whether you need support with the submission process or guidance on any aspect of FAERS, our team of experts can provide the necessary assistance. Contact us at 248-987-4497 or by email at info@emmainternational.com to learn more about our services.

References: FDA. (2018, June). FDA’s Adverse Event Reporting System (FAERS). Retrieved from https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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