US FDA Reforms In 2022: One Bill – Or Four?
The draft bipartisan user fee reauthorization bill includes more than 40 ride-along provisions to make changes at the US FDA. But there are at least three other bills moving in Congress that also make FDA reforms.
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The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.
Measures aimed at spurring biomedical innovation, ensuring fewer roadblocks to development of biosimilars and generics, and strengthening the FDA’s interactions with rare disease patients could find their way into must-pass legislation reauthorizing the human drug and biologic user fee programs by 30 September.
Senate committee approves legislation aimed at strengthening the US public health and medical preparedness and response system. Bill includes several provisions impacting FDA but not its 'gold standard' approval process.