FDA Helping to Advance Treatments Tailored to You

FDA: 10/29/13

Personalized medicine is the tailoring of a medical treatment to the individual characteristics, needs and preferences of a patient. Many recent advances involve using a patient’s genetic information to guide his or her treatment.

Developing a truly personalized approach to patient care will require fundamental advances in the understanding of the biological, anatomical and physiological mechanisms that underlie disease, and how they are affected by environmental, genetic, social and cultural factors.

To describe its unique responsibilities and its efforts in facilitating the advancement of personalized medicine, the Food and Drug Administration (FDA) has released a new report entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development (PDF 875 K).”

Advancing Regulatory Science

FDA’s commitment to personalized medicine dovetails with its focus on advancing regulatory science, which is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.

Here are some examples from the report of how FDA is using regulatory science to help speed the development of promising new personalized medicine therapies. Read More