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FDA plans new office to revamp drug review process


The United States Food and Drug Administration (U.S. FDA) has plans to create the Office of Drug Evaluation Science (ODES) in an effort to improve how new medicines are currently reviewed. According to FDA Commissioner Scott Gottlieb, who announced the plan for the new office in January, ODES would be located in the Center for Drug Evaluation and Research’s Office of New Drugs and would modernize the current drug review process by establishing a standardized approach and incorporating new types of information.

ODES will be responsible for incorporating digital data, patient-reported outcomes, and personalized medicine into their review. The office will employ 52 individuals and have divisions dedicated to promoting the development and implementation of clinical outcome assessments, biomedical informatics and safety analytics, and biomarker development.

The new office is expected to launch during the first half of this year, and Gottlieb says the FDA is hopeful that using ODES to standardize the drug review approach will limit any inefficiency, costliness, and unpredictability of the current system.

Written by Katelyn Jones, Fellow, Contraceptive Technology Innovation Exchange



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