EMA Plans Guidance To ‘Closely Knit’ Development Of Companion Diagnostics And Drugs
The European Medicines Agency has taken the first step towards the development of guidance to help optimize the co-development of medicinal products and companion diagnostics.
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The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
After some five years of working on the EU's new Medical Devices Regulation and IVD Regulation, the texts that were finally adopted on April 5, have been published in the Official Journal of the European Union.
The EMA is inviting feedback on its plans to ratify, with some caveats, a new framework on how to use patient preferences as input in medical product decision-making. The framework was developed under the EU’s public-private Innovative Medicines Initiative.