biopharmaceutical-drug-development Downloads
1 downloads found
With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the ...