Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) team up again in calling for reforms to the FDA’s authority, transparency and management in reviewing medical devices.
Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced a new bill today aimed at reducing the medical device industry’s regulatory burden.
The duo’s “Patients’ Act” (Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA) would “ensure that the FDA is held accountable for its performance goals and is fulfilling its public health mission on behalf of patients in a predictable and timely manner, including decisions on life-saving drugs and devices,” according to a press release.
The bill, intended to complement the Medical Device User Fee & Modernization Act, accomplishes this with 6 main initiatives designed to:
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