Global Medtech Guidance Tracker: October 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-six documents have been posted on the tracker since its last update.
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Proposed updates to the US FDA’s breakthrough devices program guidance would help to clarify how the program may be applicable to devices that treat and diagnose diseases that disproportionately affect certain populations.
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.