Risk, vigilance, and remediation under IVDR
The In Vitro Diagnostics Regulation (IVDR) — which goes into effect on May 26, 2022 — will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.
Managing COVID disruptions within IVDR timelines
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
Exploring the benefits of biotech partnerships
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases.
Cancer research post-COVID-19
The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools as global lockdowns reduce the ability of patients to go to clinics.
The shifting diagnostics regulatory landscape amid COVID-19
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.