FDA has issued a combined synopsis/ solicitation to meet the “requirement for the purchase and implementation of a suite of Pharmacovigilance Commercial Off the Shelf (COTS) products that is Brand Name or Equivalent to the products listed in the RFP Attachments. The purpose is to replace the FDA’s Legacy Adverse Event Reporting System (FAERS) with a new suite of Pharmacovigilance COTs products; obtain configuration / integration / implementation / and O&M support services for the new system, and ultimately improve Adverse Event case management, case processing, data analytics, and signal management.”
“FAERS is a web-based data management system that supports and facilitates post-market product safety surveillance of human drugs, biologics, devices, and combination products. It provides a data repository for collecting, storing, viewing, analyzing, reporting, and tracking the intake of adverse event (AE) data. It consists of multiple modules described under Appendix A: Adverse Event Tools and Technologies. The operations and maintenance of FAERS application is valid until FAERS II is deployed into production, contains all the legacy FAERS data and is fully operational.”
“FAERS II, the replacement of legacy FAERS shall improve the FDA’s pre-market and post-market product safety surveillance capabilities by providing a better method of processing ICSRs related to safety, medication errors and product quality reports, thereby improving analytics capabilities for downstream systems. FAERS II shall allow for easy, transparent and secure access to its critical functionalities and shall integrate multiple (and support multiple versions of) dictionaries of various types used for coding adverse event reporting data, e.g., medical terminologies, product names and active ingredients, product manufacturers, re-packers, labelers and distributors.”
Responses are due by June 26, 2018.
