Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA revokes...more
The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more
In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more
On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more
In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured...more
Earlier last week, the US Food and Drug Administration (FDA) issued new and revised guidance on its enforcement policy for face masks, surgical masks, respirators, and face shields during the COVID-19 emergency in response to...more
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19...more
Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more
What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China. ...more
Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more
All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
To address the increased usage and shortages of respirators as a result of combatting COVID-19, on 24 March 2020 the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for non-NIOSH approved...more