Regulatory Rapporteur May 2019
In This Issue FOCUS: EU Device and IVD Legislation PLUS • Producing periodic benefit–risk evaluation reports • New FDA strategy for interaction with biosimilars sponsors • Medicines development in Turkey: a regulator’s view
Regulatory Rapporteur May 2019MEMBERS
Combination products: the challenge of obtaining notified body opinionsMEMBERS
Medical device standards updateMEMBERS
Partners in progress – Cancer patient advocates and the FDAMEMBERS
New FDA draft guidance on formal meetings for BsUFA sponsorMEMBERS
The challenges of producing periodic benefit–risk evaluation reportsMEMBERS
Meet the regulators interview: The regulation of medicines in Turkey PUBLIC
EU IVD Medical Devices Regulation: what you need to know and why PUBLIC
Editorial: Light at the end of the tunnel PUBLIC
Letters to the editor: ICH Q12 guidelines, harmonised SPC for generics PUBLIC