Food and Drug Administration (FDA) Commissioner Scott Gottlieb says a plan to create a new office to bolster drug reviews is more than just an organizational shift, but a move toward greater changes, STAT reports.
The proposed 52-person branch, dubbed the Office of Drug Evaluation Science (ODES), will play a key role toward creating a standardized methodology for the use of personalized medicine, digital data and personal records.
“Eventually the drug review process will look a lot different,” Gottlieb told STAT in an email.
According to the report, Gottlieb has his eyes on a more cloud-based approach in which raw data generated by drug companies can be analyzed by the agency’s standardized methods.
“That is what I mean by a structured approach,” he said. “That is where we are heading, starting with the evaluation of safety data.”