Legally Qualified: Can Employers Require Vaccines?
Can Employers Require COVID-19 Vaccinations?
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more
The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food,...more
Yesterday, on July 27, 2021, the U.S. Center for Disease Control (CDC) issued new COVID-19 guidance, including recommending face masks even for vaccinated people when they are in indoor public settings in geographic areas...more
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
In the past week, the U.S. government announced new vaccination milestones reached and encouraged more people to get vaccinated. Please see details for these and other supply chain developments below: On April 27, President...more
The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more
As COVID-19 vaccinations progress and as our economic and social lives begin to return to normal, employers are faced with new challenges. These challenges are particularly difficult for banks and credit unions, which not...more
As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant...more
The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more
The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...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. ...more
To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...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
The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19. The Agency has articulated its guidelines for PPE in one of two ways: (1)...more
On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more
On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for...more
FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic. This May Guidance supersedes the guidance, “Enforcement Policy for Face...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
On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by...more
The Centers for Disease and Control and Prevention (CDC) is now recommending that the general public wear face masks to help slow the spread of COVID-19. Along with this recommendation, many businesses, individuals, and other...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