Gain compliance with FDA Adverse Event Reaction Reporting (FAERS) and stay on top of MoCRA’s mandates. Ensure potential safety issues with your products once they’re out in the market to avoid penalties and maintain market access.
QSS assists you with a personalized approach, advanced technology, ensuring you receive accurate, timely, and hassle-free reporting, so you can focus on what matters most—your business.
Connect with Former FDA MoCRA experts by filling out the form below.
FDA Adverse Event Reaction Reporting (FAERS) is a database for the FDA, which tracks safety concerns after drugs and biological products hit the market. It collects reports of side effects, medication errors, and product quality issues. Under the MoCRA (Medical Device and Cosmetic Act), cosmetic manufacturers have a crucial obligation to report serious adverse events associated with the use of cosmetic products within the United States. Learn about New Tools for MoCRA Compliance.
Anyone (Healthcare professionals, consumers, and drug manufacturers) can submit the report to FEARS. They can report side effects they experience from a medication, medication errors you make, or problems they have with the quality of a drug or biologic product.
Drug manufacturers can analyze the data to identify potential safety issues with their products, leading to improvements.
FDA requires all cosmetic adverse event reporting within 15 business days from the moment the company becomes aware of the event. Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the US FDA. Click here to see our pricing
Companies within the cosmetic industry should adopt the following recommended practices:
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