– The FDA is continually updating the COVID-19 section of its website. Of particular note to our members is the guidance released March 18 by the FDA in recognition of the disruption that COVID-19 has already had and will continue to have on clinical trials. The FDA issued the guidance, titled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19” (COVID-19 Guidance Document), which is available here. This guidance provides the FDA’s thoughts on how best to prepare for and mitigate the effects of COVID-19 on clinical trials.
– Similarly, the NIH is regularly updating its COVID-19 resource page with research information and related press releases. As an important source of funding for many of our member companies and academic research institutions, the NIH also released “Information for NIH Applicants and Recipients.” Additionally, the NIH put together a website with many “Frequently Asked Questions” on how travel restrictions, delays in research, and many other variables will affect funded research. I recommend anyone receiving NIH grant funding review this information if they have any questions.