No Shocks Expected In EU Quality Guidance For Drug-Device Combinations
Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.
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An upcoming requirement that Europe’s new medical device regulation has introduced for companies making drugs with integral medical devices will not be applied retrospectively, according to the European Medicines Agency.
Companies developing drugs with integral medical devices such as pre-filled syringes in the EU are desperate for guidance on how to comply with a provision that Europe’s new Medical Device Regulation will introduce for them. Speakers at a regulatory conference in Sweden had some important advice for them.