23 Nov 2021
Princeton, New Jersey, November 10, 2021 – RxLogix Corporation, a global leading provider of end-to-end Safety and Pharmacovigilance (PV) Software and Services, today announced the Go-Live of FAERS II at the United States Food and Drug Administration (FDA). FAERS II utilizes the RxLogix integrated PV signaling platform consisting of PV Signal, PV Reports, and PV Analytics. The CDER & CBER at the FDA are responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs and biological products. In order to perform state-of-the-art data analytics and signal management, the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) has implemented the RxLogix PV Signal, PV Reports and PV Analytics as part of a larger effort to modernize and enhance the FDA Adverse Event Reporting System (FAERS).
FAERS II is a holistic and integrated platform for safety surveillance, and analytics for approved drugs. The integrated pharmacovigilance platform will streamline regulatory processes and ensure data quality to facilitate full lifecycle safety surveillance and tracking. The integrated platform consists of RxLogix’s PV Signal and Reports (RxLogix) for data analysis, reporting, and visualizations.
This first release of FAERS II replaces the previous version of FAERS to support FDA’s post-market stakeholder community, including the Office of Surveillance and Epidemiology Division of Pharmacovigilance, the Office of Generic Drugs Division of Clinical Safety & Surveillance, and the Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology.
RxLogix PV Signal is the industry’s most complete signal detection and management platform that provides a dynamic data mining and data analytics environment for detecting signals, uncovering patterns, and recognizing emerging trends in adverse event report data. RxLogix PV Reports is the most advanced, user-friendly, and self-service tool for Regulatory Reports, Ad-hoc Reports, with out-of-the-box Spotfire Integration and Visualizations.
“This is a major milestone for our company. We are extremely proud of our integrated signal detection platform being selected by the FDA, one of the world’s leading regulatory agencies, to perform safety surveillance for the United States. We aspire to be the signal detection platform of choice for regulatory agencies around the world”. said Raj More, CEO and Chief Architect at RxLogix.
PV Reports – https://www.rxlogix.com/pv-surveillance/pv-reports/
About RxLogix Corporation
RxLogix is a global pharmacovigilance solutions company specializing in innovative software and expert consulting services. Our talented team of business and technology innovators works with Pharmacovigilance and Risk Management Professionals to help increase the compliance, productivity, and quality for the entire Drug Safety value chain. We are business transformers, digital thinkers, tech Innovators, technology revolutionist, business mavericks, driven and open-minded individuals. At RxLogix, our goal is to make the most innovative industry standard software for the life sciences domain.
RxLogix, PV Signal, and PV Reports are registered trademarks of RxLogix Corporation. Other names may be trademarks of their respective owners.
500 College Rd East, Suite 410
Princeton, NJ 08540, USA