The Food and Drug Administration will soon standardize the way it handles data on the safety and effectiveness of drugs in an effort to reduce inconsistencies in the drug review process, agency Commissioner Scott Gottlieb said Friday.
“Rather than just looking at drug safety parameters in terms of the tables that are submitted to us, we’re going to actually take the raw data and evaluate it into custom tables, that the agency’s going to develop, that are going to be standardized across all our review divisions,” Gottlieb said.
The timeline for the change is unclear; Gottlieb said only that he will “speaking more” about the change in October. He said the agency will prioritize the change for drug safety data, but could ultimately apply it to drug effectiveness data, too.
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