The COVID-19 Adverse Event Dashboard

by | Mar 24, 2021 | COVID-19, FDA, Medical Devices, Pharma, Quality, Real World Evidence, Regulatory

The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and query adverse event data. The tool intends to provide users access to adverse event reports submitted by the pharmaceutical industry, health care practitioners, and consumers.1

As the number of drugs and biologics authorized under the COVID-19 EUA umbrella is increasing, FDA realized the need to capture information for COVID-19 emergency use authorization products. The COVID-19 EUA FAERS public dashboard updates weekly with adverse events related to drugs and biologics authorized to be marketed under the COVID-19 EUA.1

While FAERS is a helpful tool to provide information about adverse events reported to the FDA, there are certain limitations to this data:1

  • While the FAERS reports contain information about the usage of the drug or biologic it does not necessarily mean that the drug or biologic caused the adverse event. The event may have been caused by underlying diseases, comorbidities, or some other drug.
  • There may be duplicate or incomplete reports in the system and may not provide all the required information.
  • The information submitted in these reports has not been verified by any health care agency or medical experts.
  • These reports cannot be used to establish incidence or occurrence rates.

Users should also note that the data in FAERS is not an indicator of the safety profile of the drug or biologic.  The data uploaded to the FAERS is important to the FDA to look for new safety concerns, evaluate the manufacturer’s compliance with the regulations, etc. These reports are also evaluated by FDA’s clinical reviewers for trends that help the Agency to take appropriate actions such as inspections and other types of enforcements.1

The FAERS is a step towards FDA’s initiative to collect real-world evidence and use it for monitoring purposes. I strongly believe that initiatives such as the NEST program (National Evaluation System for Health Technology) will further advance this effort and allow for more evidence-based decision-making. EMMA International is here to help you with all your quality and regulatory needs. Call us today at 248-987-4497 or email us at info@emmainternational.com to find out more.


1FDA (2021) FDA Adverse Event Reporting System (FAERS) Public Dashboard retrieved on 03/20/2021 from https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This