Posted by Michael Wonder on 30 Mar 2020
FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic
30 March 2020 - The U.S. FDA today issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject.
The FDA plans to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards.
The FDA issued this guidance because we recognise that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products. For example, challenges may arise from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19. These challenges may lead to difficulties in conducting the clinical trials.
