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PMTA applications: how the FDA’s policy has developed

Written by || 26th June 2016 || Regulatory reports , Topic regulatory reports || Policy and Politics | Regulation and Legislation | North America United States

Many questions remain over how the FDA will actually interpret the requirements for authorisation: how rigid a view it will take on the evidence required to support an application, for example. Comparing a leaked earlier version of the regulations with the final published version provides some clues. ...

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