Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance
The Effective Statistician - in association with PSI
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Is There a Way to Define a Piaro Hed Point in a Label?
Sali: For a c o a to be really considered for a label claim, it needs to be clearly defined and also included in the orsort of m point testing strategy. Sali: Er, that concept was touched on elsewhere in here, but er, there's not any real lots of detail, per say, in the draft document. But i thing tat is pulling it out, you know, don't just oos expect to put a pron point in and not do something that's robust to test that treatment affar.
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