Mar24Tue

FDA Guidance on Clinical Trials + Other Federal Updates

Many thanks to Life Sciences PA for sharing regular updates.

As the COVID-19 outbreak continues to disrupt our health care system and our day-to-day activity, we know many of our member organizations continue to pursue treatments and technologies for patients facing the coronavirus as well as many other diseases. As your research and development efforts move forward, we want to be sure you are up to date on the activity of two federal agencies with whom many of our members regularly interact – the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). While both are devoting significant resources to fight the pandemic, they are also ensuring other research and development efforts progress.

– 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.

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