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Focus on Regulation Blog

Articles: 1-10 of 345

The EMA launches a public consultation on eSource Direct Data Capture in clinical trials

European Union - November 28 2018 The European Medicines Agency (EMA) has published a draft qualification Opinion[1] concerning the use of eSource Direct Data Capture (DDC) in the…

EMA launches public consultation on the use of patient disease registries for regulator purposes

European Union - November 28 2018 On 5 November 2018, the EMA published a Discussion Paper concerning the use of patient disease registries for regulator purposes. The Discussion Paper…

“Specific Instances” under OECD Guidelines - What can financial institutions learn from the recent ANZ case on providing finance to a company engaged in human rights abuses

Global, OECD - November 26 2018 The Australian National Contact Point for the OECD Guidelines for Multinational Enterprises (“AusNCP”), which handles “specific instances” relating to…

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

European Union - November 26 2018 The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations…

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

European Union - November 23 2018 On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in…

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

European Union - November 19 2018 The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for…

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

USA - November 15 2018 On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile…

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

USA - November 8 2018 On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes…

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

USA - November 7 2018 On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical…

EMA warns marketing authorisations holders to notify type I variations earlier

European Union - November 5 2018 On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary…