EU MDR/IVDR
The European Medicines Agency (EMA) has published guidelines dedicated to the quality documentation to be provided for medicinal products intended for use with medical devices. The present article addresses matters related to medicinal products with co-packaged or...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to labeling requirements. The aspects covered by the scope of the guidance include labeling requirements for...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a detailed guidance document dedicated to labeling requirements for various types of medical devices, including in vitro diagnostic...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to early collaborations meetings to be carried out in order to improve cooperation between the Agency and...
EU MDR/IVDR
The European Medicines Agency (EMA) has published a guidance document dedicated to the quality documentation for medicinal products when used with a medical device. The present document constitutes a final version which will enter into force on January 1, 2022. Table...
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