FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Touts New FDA Science Office, Push for Generic Approvals in 2019

Jan. 17, 2019

FDA Commissioner Scott Gottlieb announced the creation of a new office to help streamline the agency’s review of new drugs.

The Office of Drug Development Science (ODES) will operate within CDER’s Office of New Drugs and work to standardize the review process, he said. 

Gottlieb compared the new office to the 2003 creation of the FDA’s modeling and simulation office, which also was the result of the agency seeing a tool become more important within drug development and incorporating it into the development process.

“The goal of these new offices is recognizing these tools [such as biomarkers, biomedical informatics and real-world evidence] becoming more integral components of the drug review process,” he said.

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