FDA/Industry Interactions Might Get Revised Rules Of Road After Opioid Publicity
Sen. Manchin calls for congressional investigation of “pay to play” allegations; FDA maintains the meetings with industry were for scientific, not regulatory purposes, but the agency is looking into the matter.
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She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.
Agency’s goal of setting standards for clinical data in 57 therapeutic areas in five years looks unlikely to be met, according to the timelines given by members of the Coalition For Accelerating Standards and Therapies.
The agency reiterates its commitment to protecting scientific integrity in response to the Union of Concerned Scientists’ survey of FDA scientists; staff cite corporate influence on agency decisions and fear of retaliation for expressing their concerns.