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NHS England Publishes Draft Commercial Framework for Medicines

United Kingdom, USA - November 14 2019 NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded…

Brian Kelly, Grant H. Castle.

EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

European Union - October 21 2019 The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect…

Sarah Cowlishaw.

CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data

USA - October 13 2017 On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the…

Daniel Pavin.