EU Medical Devices Regulation Series: Potential for Easing Borderline Determinations?
EMA Publishes Proactive Disclosure Guidance
EU Agreement on a General Approach on the Medical Devices Package
IVD Regulation and Companion Diagnostics – EU Council Dramatically Changes Definition
General Court Confirms Market Exclusivity Rights in CTRS Case
EFSA Grants Public Access to Data through Scientific “Data Warehouse”
Article 29 Working Party Clarifies Scope of Health Data in Apps and Devices
EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation
Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13
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