FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications


24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many times when a drug provides important benefits, but also has serious risks. 

In some cases, if there is a greater assurance that those risks can be properly managed, then the benefits can support approval. This is the field of risk management, and it’s a critical function here at the agency.

Today, we’re announcing the availability of two draft guidances that will help improve our ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working. These risk mitigation programs can help make sure that benefits of these products continue to outweigh the risks.

Read FDA statement

Michael Wonder

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Michael Wonder