One of the bedrock consensus issues throughout the drafting of the “21st Century Cures” legislation has been that the bill should create a pathway for approval of new antibacterials for limited populations – the LPAD pathway. But what would it actually do?
A limited use approval pathway is one of the more intriguing components of the “21st Century Cures” FDA reform provisions. As the legislation moves to the Senate, FDA is joining other stakeholders to outline its vision for how the new authority would work. https://www.pharmamedtechbi.com/publications/rpm-report/first-take/2015/3/lpad
The question: are you sure that you belong to this limited part of population???
A limited use approval pathway is one of the more intriguing components of the “21st Century Cures” FDA reform provisions. As the legislation moves to the Senate, FDA is joining other stakeholders to outline its vision for how the new authority would work. https://www.pharmamedtechbi.com/publications/rpm-report/first-take/2015/3/lpadThe question: are you sure that you belong to this limited part of population???
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