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FDA Adverse Event Reporting System

FDA Adverse Event Reporting System (FAERS)

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CQ Enterprise Quality Management System

What is the FDA Adverse Event Reporting System (FAERS)?

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What is the FDA Adverse Event Reporting System?

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event reporting regulations, is designed specifically to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. FAERS database adopted an informatic structure based on the guidance issued by ICH E2B or International Conference on Harmonisation. All approved drugs adverse event reports must be submitted by the manufacturer to FAERS electronically using the ICH E2B XML format which replicates Form FDA 3500A.

FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include –

  • Looking out for new safety concerns that might be related to a marketed product
  • Evaluating a manufacturer’s compliance to reporting regulations
  • Responding to outside requests for information

An adverse event can be defined as any side effect or unexpected experience witnessed by humans with the use of a drug or other therapeutic biologic, irrespective of its relation to the use of the product. An adverse event could occur:

  • with use in professional practice
  • due to lack of expected effectiveness
  • from accidental or intentional overdose
  • from drug or product withdrawal
  • from excessive use or abuse of product usage

All adverse events and medication errors are coded based on the Medical Dictionary for Regulatory Activities (MedDRA) terminology. FDA established FAERS to handle reports of the following nature –

  • Unexpected complications or side effects, including skin rashes to any serious complications
  • Defects or other quality problems as a result of product performance
  • Potentially avoidable mistakes that can be caused due to packaging or labels that look similar, or usage difficulty due to the presence of hard-to-read displays or controls
  • Food concerns, including allergic reactions or illness
  • Medical device therapeutic failures

Consumers who wish to report an adverse event to FDA can do so using the online reporting form insteading of expecting the healthcare provider to report to FDA. The report will include personal information about the consumer, product details, problem or reaction, and any other medical treatments or outcome. To submit voluntary adverse events reports, consumers can follow any of the following methods

  • Online reports
  • Call FDA by telephone at 1-800-FDA-1088
  • Fax or email Consumer Reporting Form FDA 3500B
  • Reporting Form FDA 3500
FDA Adverse Event Reporting System (FAERS)

Why FDA Adverse Event Reporting System

Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.

If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take regulatory action(s) to improve product safety and protect public health, such as

  • OSHA -1
    Restricting the use of the drug
  • OSHA -2
    Updating a product’s labeling information
  • OSHA -3
    Communicating new safety information to the public
  • OSHA -4
    Removing a product from the market
  • OSHA -2
    Issuing new safety alerts
  • OSHA -3
    Inspecting the product manufacturer
  • OSHA -4
    Ordering further studies to demonstrate product safety

FDA regulates several products across industries. FAERS can be used to report any of the following products

  • OTC and other human prescription drugs
  • Medical devices
  • Radiation emitting electronic devices
  • Vaccines
  • Veterinary products
  • Tobacco products

Who can use the FDA Adverse Event Reporting System to submit a report?

The reports submitted through FAERS are evaluated based on clinical reviewers’ various parameters in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). FAERS reports can also be submitted online. Reports can be submitted to FAERS by

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    Consumers, including patients, lawyers, family members
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    Healthcare professionals, including nurses, physicians, and pharmacists

Further, manufacturers can receive reports from consumers and healthcare professionals. If a manufacturer is in receipt of such reports, they are required to send the report based on the regulations specified by the FDA.

FAERS reports can be submitted online, through a consumer reporting form such as FDA 3500B, or through telephone. Some of the FDA regulated products are

  • Cosmetics
  • Food
  • Combination products
  • Medical devices
  • Special nutritional products
  • Biologics
  • Prescriptions or over-the-counter medications

Roles of FDA Adverse Event Reporting System in Organizations

FAERS public dashboard is user-friendly as it offers data based on query in the form of information and charts. The data is also searchable based on product or timeframe. The data from FDA Adverse Event Reporting System (FAERS) is available readily to the public in various forms, including highly interactive web-based FAERS dashboard, extracted FAERS data files of individual case safety reports from FAERS database, and individual safety files that can be acquired through a Freedom of Information (FOI) request to FDA.

  • ISO 9001
    Monitor new events and medication error in new products
  • ISO 9001
    Measure harm from medications
  • ISO 9001
    Ascertain the risk-benefit ratio to determine the continuity of the drug
  • ISO 9001
    Monitor safety of product after FDA’s approval

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How to handle FAERS reports with ComplianceQuest?

FDA and ISO compliant environments are stringent about non-conformance of product, material, or component. Nonconformance and elimination of its cause are critical to an organization’s quality system. Failure to conform or report to FAERS can lead to costly rework or a product recall. With CQ Nonconformance Management Solution, companies can capture, triage, investigate and dispose of all non-conformances in a timely and effective manner. Our primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.

Frequently Asked Questions

How can QMS help with FDA compliance?

Identifying and managing product and process Nonconformance and eliminating its cause is critical to an organization’s quality system. This is especially pertinent in the stringent FDA and ISO-compliant environments, where a non-conforming product, material, or component could lead to costly rework, or worse, a product recall. CQ’s primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.

  • Reduce CoQ due to internal failures with a collaborative approach to nonconformance management, organization can prevent any variance to process, parts, or equipment and ensure periodic training of shop floor workers to align to the ever-changing quality parameters
  • Leverage Einstein predictive analytics to spot nonconformance trends and draw insights from data, escalate to a CAPA ahead of time and drive Continuous Improvement (CI) of the entire quality management process
  • Catch nonconformance early before it reaches a customer and prevents a potential injury for the end-user, avoid unnecessary penalties/fines and protect brand image
  • With robust process control to reduce quality gaps and conform to product specifications, attain greater customer satisfaction by reducing client objections
  • CQ’s EQMS automates ISO and FDA-compliance using a risk-based approach to prioritize nonconformances and initiate corrections
  • Using an integrated Risk Management Module, automate nonconformance management workflows to identify, document, and prevent nonconformances, with a specific focus on high-risk nonconformances to minimize risk
What are the different areas to focus on with CQ Nonconformance Management Solution?

CQ’s Nonconformance management solution supports the entire organization from management to suppliers in the following ways –

  • Management – Get visibility across NCRs in real-time to quickly identify systemic issues, reduce cost, and prevent a recurrence
  • Quality – Improve process control to reduce quality gaps, lead time, increase production yield and prevent a nonconforming product from reaching the marketplace
  • Manufacturing – Enable teams to quickly capture, triage, find the root cause, and take any remedial steps to effectively prevent waste, rework, and delays
  • Engineering – Quickly access necessary nonconformance data to perform investigation and risk assessment to eliminate the root cause(s)
  • Operations – Easy retrieval of information to reduce review cycle time and for data-driven decisions to authorize disposition of nonconforming material
  • Supplier – Gain visibility, improve collaboration and minimize lag times for supplier corrective actions
What are the features of the CQ Nonconformance Management Solution?

CQ’s Nonconformance management solution enables organizations to quickly identify and fix the underlying cause of nonconformance or unplanned deviations. Some of the features of the solution mentioned below –

  • Identification – Streamline recording and management of all types of events from single or multiple sites in one centralized system
  • Documentation – Simple, easy-to-use user interface to document allows instances of nonconformance from one or multiple sites
  • Evaluation – Comprehensive triaging, risk assessment, and documentation of results to provide direction for the required resolution
  • Containment – Enforce containment activities to control and prevent improper usage of nonconforming material
  • Disposition – Employees from one or multiple sites and divisions can collaborate to propose different disposition types and hold virtual material review boards
  • Root Cause Analysis – Perform root cause analysis, document the outcome in detail, and submit for CAPA evaluation
  • CAPA evaluation – Evaluate every nonconformance or event against the CAPA requirements of the organization and generate CAPA if required
  • Collaboration – Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up ownership of the tasks
  • Mobile access – Complete access to the QHSE solution including reports, approvals, record views, reviews, alerts, etc., on mobile for business continuity

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