The COVID-19 pandemic interrupted many aspects of our lives as we know it. One of the critical concerns on the FDA list is how to handle the ongoing clinical studies during the current pandemic. With that in mind, FDA issued a new document titled “FDA Guidance on Conduct of Clinical Trials of Medical Products During
We have reported previously that US FDA stopped sending their personnel to inspect foreign manufacturers in China due to widespread outbreak of COVID-19. As reported today, the FDA is now postponing most foreign inspections through April, effective immediately. However, inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For US-based
The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat “Novel Coronavirus Disease 2019” (COVID-19). These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA is particularly concerned that products that claim to cure, treat or prevent
This week the commissioner of the FDA released a new update regarding the effects and response of the FDA in relation to the Coronavirus. The FDA has emphasized that they are taking a multi-faceted approach to this public health emergency. This approach includes facilitating efforts to diagnose, treat, and prevent the disease; surveilling the medical
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