This past week the United States surpassed the grim milestone of 200,000 COVID-19 deaths and seven million cases of COVID-19. The spread of the virus has altered the way we work, live, and play around the world and will soon
COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts
On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20. Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow…
COVID-19 Update: The Joint Commission Resumes Laboratory Survey Activities
In a special LabFocus The Joint Commission revealed they have resumed some laboratory survey activities. TJC stated that “[a]ccount executives are contacting organizations due for a survey to assess the impact that the coronavirus pandemic had on their operations and…
COVID-19 Update: World Health Organization Warns of Dangerous Phase
During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.” June 22, 2020…
COVID-19 Update: CDC Issues Guidelines for Events and Gatherings
On Friday June 12 the U.S. Centers for Disease Control and Prevention (CDC) published guidelines for events and gatherings ranging from lowest risk (virtual-only) to highest risk (large, in-person, where difficult to space at least six feet apart and attendees…
COVID-19 Update: CDC Releases Interim Guidelines on Antibody Testing
On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests. The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to…
COVID-19 Update: CDC Publishes Additional Guidance on Reopening
The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations. The document, entitled CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening …
COVID-19 Update: CDC Releases Guidance for Reopening
On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities. The decision tools state that “[i]t is important to check with state and local health officials and…
COVID-19 Update: FBI Warns of Hackers Targeting COVID-19 Research
In a Public Service Announcement issued May 13, 2020, the U.S. Federal Bureau of Investigation (“FBI”) and Cybersecurity and Infrastructure and Security Agency (“CISA”) warned of the targeting and compromise of U.S. organizations conducting COVID-19 research. More specifically, the announcement…
COVID-19 update: WHO urges cautions on immunity passports
As countries around the world seek creative policy solutions to permit the opening of their economies, the World Health Organization (“WHO”) released a Scientific Brief on April 24, 2020 finding that “[t]here is currently no evidence that people who have…