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The European Medicines Agency EMAA) has released recent guidances that meet these objectives and set logical, reasonable, and achievable standards for such studies [ 36, 37].
Although the context for the FDA and EMA documents is to develop PRO instruments to support labelling, there are some methods in these guidances that may apply to non-labelling objectives.
We await the release of updated trial guidances that focus on feasibility and scientific and clinical rigor such that meaningful non-inferiority trials can be conducted to enable important new therapies to become available for our patients [ 17].
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"This is out there as guidance, but it's guidance that isn't regularly followed".
I knew right away it was divine guidance that caused me to see that tweet.
Any guidance that calms the industry and reduces the hyperbole would be welcome.
Firstly, we could arm ourselves with the legal documentation and guidance that can support our views.
The coalition has introduced guidance that allows teachers to discipline pupils outside the school grounds.
That is what the guidance that has been given by the MPC is designed to avoid," he said.
He worried that the new faculty were being deprived of the "ethical guidance that comes from listening to older teachers".
As for policy action that would back forward guidance, that is growing more unlikely by the month.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com