Blogs

Focus On Regulation

Selective Distribution & Online Sales: Higher Regional Court of Frankfurt confirms CJEU findings and provides further guidance

After the Court of Justice of the European Union (CJEU) had issued its landmark judgment in the Coty case1 on reference for preliminary ruling, the Higher Regional Court of Frankfurt (HRC...

Read more Share

HMA-EMA’s work programme on availability of authorized medicines for human and veterinary use includes measures for Brexit

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA),...

Read more Share

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are...

Read more Share

The Trump administration issues its R&D budget priorities for FY 2020

On July 31 the Director of the Office of Management and Budget, Mick Mulvaney, and the Deputy Assistant to the President, Office of Science and Technology Policy, Michael Kratsios, jointly...

Read more Share

MDR and IVDR: the European Commission published some guidance documents

In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices...

Read more Share
Loading data