March 18, 2021
F. Lisa Murtha was Quoted in Bio World's article Is U.S. FDA getting tougher under Biden? on the future of the FDA under the new administration in Washington.
“It would not be surprising if we see an uptick in new positions [at the FDA] focused on oversight and enforcement,” she told BioWorld. “But again, we have seen that in the past when a Democrat is in office.”
Other concerns also will factor in, Murtha said, noting that “the speed of the development of new drugs and biologics, and the variations we are seeing in diseases and how they present, will necessitate agency vigilance going forward.”
As new leadership comes on board and as the FDA transitions to its new normal, Murtha said she would advise drug and device manufacturers “to take great care moving forward.” That includes stepping up monitoring activities in clinical trials and documenting all activity well, particularly adverse and unexpected events.
She also advised heightened diligence in evaluating development partners such as investigators, institutional review boards and contract research organizations to ensure they are compliant. “We should expect more FDA site visits and more enforcement activity going forward,” she said.
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