The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an...more
On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk...more
On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.
In that Alert, we included the prediction by the Centers for...more
FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.
On February 22, FDA issued a new Guidance for...more
The novel coronavirus undergoes a mutation about once every 2 weeks, or half the rate seen in influenza.
What to Know -
Mutations of the virus have given rise to thousands of variants, only a few of which currently...more
Prop 65 Violation Notices Jumped in California as COVID-19 Shutdowns Began -
ChemicalWatch -
The number of violation notices filed under California’s Proposition 65 jumped earlier this year, as much of the state began...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
The latest clinical data casts doubt on the safety and efficacy of these antimalarial drugs for treatment of COVID-19, and both the FDA and an Expert Panel of the NIH have just warned against their use outside of clinical...more
On April 14, 2020, the journal Science published on-line a “First Release Notification” paper entitled “Projecting the transmission dynamics of SARS CoV-2 through the postpandemic period” by scientists from the Departments of...more
As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected...more
4/9/2020
/ Best Practices ,
Biologics ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Face-Filtering ,
Health and Safety ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Medical Devices ,
OSHA ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments...more
Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.
On March 24, FDA announced that it would allow the use of convalescent plasma from recently recovered COVID-19...more
In a letter dated March 28, FDA announced it was issuing an Emergency Use Authorization for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.
The drugs are to be...more
Should Ibuprofen Be Used to Combat Coronavirus Fever?
The mechanism of attack by the novel coronavirus SARS-CoV-2 on human cells is thought to involve a specific region, known as the receptor-binding domain (RMD), located...more
Food Safety
On March 9, the European Food Safety Authority announced that there is no evidence that food is a source or transmission route for coronavirus. FDA has taken the same position, both in a stakeholder briefing held...more