Medical Device Legal News with Sam Bernstein: Episode 9
As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...more
Our annual Clinical Practice Compliance Conference provides information about the latest government initiatives related to physicians and clinics, and physician integrity trends. Unite with your colleagues to discuss...more
FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices....more
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more