Are you a drug or biologics manufacturer willing to submit adverse event (AE) report with respect to your product to the United States Food and Drug Administration (USFDA)? Or are you a healthcare professional or a consumer planning to report AE or medication error to the US health agency and/or willing to access the safety information related to a specific drug? Then, here is an announcement for you. The USFDA, on 27th Sep 2017, has officially launched searchable public dashboard for its drugs and biologics AE database. It is known as the FDA’s Adverse Event Reporting System (FAERS).

FAERS is said to be a path-breaking innovation in the field of drug-safety monitoring. Conceptualized to accelerate product safety and improve public health, FAERS supports the FDA’s post-marketing drug safety monitoring efforts availing a wealth of voluntarily contributed healthcare information, contributed by manufacturers, healthcare professionals, and consumers.

Some outstanding characteristics of FAERS include:

  • FAERS is a free and publicly available resource
  • FAERS supports the FDA’s post-marketing drug safety monitoring efforts
  • The health information gained from FAERS is used for a variety of purposes, including health surveillance, drug safety signal detection, improving health service delivery and drug Regulatory purposes, among several others
  • FAERS helps identify contemporary trends in the prevalence of diseases and AEs
  • FAERS also helps guide the development of research studies in the field, and
  • Identify new opportunities in Regulatory science as well as translational medicine

FAERS accepts drugs and biologics AE reports from both the parties, either Voluntary (reports from healthcare professionals – Physicians, Pharmacists etc., and Consumers – patients, lawyers etc., or Mandatory (reports from facilities, manufacturers, applicants etc.). Mandatory reporters can submit their report electronically, for which they can access FAERS Electronic Submissions website.

Regardless of its numerous benefits, FAERS was under fire for some time due to various reasons. However, what FAERS certainly helps to do is intelligently integrate and streamline the wealth of health-related data. In doing so, it addresses various bio-medical challenges, accelerates drug safety research and enables standardized analyses using common vocabularies.

To keep abreast of more information on Regulatory industry, get in touch with Freyr, a specialized Regulatory intelligence provider with a worldwide affiliate network across 120+ countries.

Should you need any assistance on preparing Periodic Adverse Drug Experience Report (PADER), leverage Freyr’s expertise in electronic compilation of PADER and conversion of existing paper-based PADER to eCTD format.

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