The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT.
The new office will help develop a standardized approach to using personalized medicines, digital data and patient data. One of the main goals will be understanding how to turn what patients tell physicians into structured, actionable data.
The office will be part of the Office of New Drugs, which sits in the FDA's Center for Drug Evaluation and Research, the overseer of new medication approval. It will have its own director, an 18-person division of clinical outcomes assessment team; an 18-person division of biomedical informatics and safety analytics; and an 11-person division of research and biomarker development.
FDA Commissioner Scott Gottlieb, MD, expects to set up the office in the first half of the year.