Tag archives: public health

COVID-19 Update: FDA will use enforcement discretion for limited ventilator modifications

On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic. FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to … Continue reading

COVID-19 Update: HHS Declaration Provides Liability Immunity Related to Certain COVID-19 Countermeasures

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 23, 2020 Posted in Coronavirus, General, News from DC, Regulatory

The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency. On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures … Continue reading

U.S. Declares Coronavirus a Public Health Emergency

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 3, 2020 Posted in Coronavirus, General, International, News from DC

As of Monday February 3, the death toll of the Coronavirus had risen to 362 and there were over 17,300 known cases around the world. The number of coronavirus deaths in China has now exceeded the severe acute respiratory syndrome epidemic in 2003. There have been eight confirmed cases in the United States, with Massachusetts … Continue reading

WHO Deems Coronavirus Global Health Emergency and White House Announces Task Force

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 31, 2020 Posted in Coronavirus, General, International, News from DC

On January 30, 2020, the World Health Organization (WHO) declared the coronavirus a global health emergency. The coronavirus has now been identified in 18 countries and has infected 9,709 people. 213 people have died from the coronavirus. Countries are beginning to evacuate citizens from China and the United Kingdom, Australia, South Korea, Singapore and New … Continue reading