EMA-raadpleging: conceptdocument over de noodzaak van herziening van de nota over richtsnoeren voor klinisch onderzoek van geneesmiddelen voor de behandeling van perifeer arterieel vaatstelsel
The European Medicines Agency has released for public consultation a draft concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease.
Peripheral arterial diseases (PADs) encompass all arterial diseases other than coronary arteries and the aorta. Currently, the main focus of pharmacotherapy has been on the lower extremity artery disease (LEAD) and this is also reflected in the scope of the current CHMP Note for Guidance (peripheral arterial occlusive disease affecting the arteries of the lower extremities).
In light of the developments in the field of PADs, the title/scope of the guideline needs to be rediscussed to decide if other locations in addition to the lower extremities need to be covered or the title adapted to reflect limiting the guidance on the lower extremity disease only
The concept paper is available by clicking here.
Comments should be provided using this template and sent to CVSWPSecretariat@ema.europa.eu by 30 June 2019.
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