About CERTs
Annual Report Year 2
Focus on the Program
The Risk Series | PATHs to Knowledge | On the Horizon
The Risk Series
Communication Risk | Risk/Benefit Assessment | Risk Management
Because no medical product is absolutely "safe," the U.S. system of developing medical products involves trade-offs-a certain amount of risk given a certain amount of benefit. Products approved for marketing thus reflect a balance between the known benefits and the known risks as used in a specific population.
When products are used inappropriately, however, or their use is not monitored properly, the risk of adverse effects can increase. In more and more cases, continued inappropriate use or inadequate monitoring has resulted in the removal of products from the market, thereby reducing treatment options for all of us.
The CERTs program as a whole is working to reverse this trend. In partnership with FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), and AHRQ, we are tackling the issue of risk through a series of expert workshops. These workshops are focusing on three broad categories related to risk: communication, assessment, and management.
The ultimate goal of the Risk Series is to put forth an agenda for research priorities relating to the risks of medical products.