Statement from FDA Commissioner on new FDA efforts to support more efficient development of targeted therapies


15 December 2017 - In recent years, the medical community has experienced a shift in the way health care is practiced. 

Rather than focusing solely on how to treat an overall disease type, medical innovators are now exploring how to tailor treatments that target unique characteristics of an individual’s disease, such as the genetic profile of a person's tumor. Innovation in this modern, targeted approach to medicine has already led to new more targeted medicines and, in some cases, therapies that are tailored to individual patients.

The FDA has an important role to play in advancing this targeted approach to treating disease by building a modern framework that ensures we’re providing the guidance and resources needed to efficiently develop these novel products using new technology. In particular, the FDA needs to clarify and expand an existing pathway that allows innovators to develop products based on the molecular markers that the drug targets, rather than the more traditional approach to drug development, where new medicines were developed based on the disease phenotype that they targeted.

Read FDA statement

Michael Wonder

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Michael Wonder