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Regulatory News | 28 May 2014 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines.
At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conference on Harmonisation's (ICH) Individual Case Safety Reporting (ICSR) format.
According to FDA, its pilot project is meant to "evaluate" its current system, presumably to determine if any changes or improvements are necessary.
FDA said it also wants to assess the use of ICH's E2B(R3) specification, which it says is "intended to improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports." The E2B(R3) standard was adopted by FDA for use in February 2014.
The pilot program is expected to last for three months, but may last longer on an "as needed" basis, FDA wrote. FDA is accepting no more than six industry participants to be involved with the program.
Federal Register Announcement
Tags: US, FDA, CBER, Vaccine, VAERS, ICSR, Adverse Event, E2B (R3), ICH, Pilot Program