With the FDA’s emergency use authorization (EUA) and now widespread availability of multiple COVID-19 vaccines in the United States, an increasing number of public and private entities are considering requiring or have...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
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
The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and,...more
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous February 29, and March...more
This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment...more
This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic. As reported in the news on a...more
News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.
Masks, ventilators, and gowns are...more