The FDA will develop more standardized, streamlined, and structured processes for reviewing new drugs, FDA commissioner Dr. Scott Gottlieb announced Tuesday.
To do that, the agency will create a new group, the Office of Drug Evaluation Science, whose 52 members will assess drug efficacy and safety, explore how to use information technology, and monitor how biomarkers are researched.
“This is going to be a new paradigm as we modernize the drug review process,” Gottlieb said, speaking to an audience at the J.P. Morgan Healthcare Conference in San Francisco. Gottlieb was supposed to appear in person at the conference, but because of staff shortages resulting from the government shutdown, appeared via video conference from Washington.
The new group will take a more structured approach to data analysis, Gottlieb said. The data they study will come from the cloud, which could make them more numerous and more readily available. The office will begin its work with a structured review of data that examines the safety of new drugs. It will also evaluate biomarkers, bioinformatics, and patient-reported outcomes.
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