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In particular, the definition of a therapeutic indication is a critical step in regulating medicinal products, and differences in the wording of indications can have a huge impact on clinical practice by including or excluding certain patient populations from the available therapies. Most if not all of the differences in authorisations in oncology are not about drugs with clear efficacy benefits compared with risk, but concern agents where there is highly complex detail about narrow therapeutic margins between benefit and harm, so it may not be surprising that different committees of scientific advisors can in turn influence decision makers at the EMA and FDA to come down narrowly on one side or another

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