COVID-19 Treatments: Regeneron Antibody Cocktail

Recently, several treatment options have become available to treat the most seriously ill COVID-19 patients. Antivirals such as Remdesivir and corticosteroids such as Dexamethasone are now being used to improve the recovery time and mortality rate among hospitalized patients. However, their curative effect against COVID-19 has not yet been established and these treatments are not widely available to the public.

Industry NewsNaveen AgarwalOctober 19, 2020COVID-19, covid-19, coronavirus crisis, coronavirus pandemic, coronavirus, EUA, FDA EUA, Regeneron, antibody cocktail, covid-19 treatmentsComment

FDA Authorizes a COVID-19 Diagnostic Test for Asymptomatic Individuals

One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. According to some estimates, nearly 40% of the new cases of SARS-CoV-2 infections do not have any visible symptoms. As a result, many of those infected are not aware they are carrying the virus and may be inadvertently adding to the rising rates of new infections. A newly authorized diagnostic test for asymptomatic patients could help.

Regulatory News, Industry NewsNaveen AgarwalAugust 3, 2020COVID-19, covid-19, asymptomatic, diagnostic testing, diagnosis, FDA regulation, FDA News, FDA authorization, coronavirus crisis, coronavirus, FDA approves coronavirus tests, FDA approvalComment

Understanding the Risk of Using Reprocessed N95 Masks During Covid-19 Pandemic

Shortages of N95 masks are forcing desperate measures. Decontamination of masks for multiple uses is a viable, low-risk-option under these extreme circumstances.

Risk ManagementNaveen AgarwalApril 6, 2020covid-19, COVID-19, coronavirus, coronavirus crisis, conronavirus pandemic, N95 masks, n95 mask shorage, FFRs, filtering facepiece respirators, CDC guidanceComment

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.

Industry NewsNaveen AgarwalMarch 21, 2020COVID-19, coronavirus, coronavirus criss, medtech, coronavirus pandemic, FDA regulation, FDA authorization, FDA approves coronavirus tests, emergency use authorization, SARS-CoV-19Comment

How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Global outbreak of the recent novel coronavirus needs an all-hands-on-deck approach. Here is how QA/RA professionals in the medical industry can help.

Industry NewsNaveen AgarwalMarch 5, 2020coronavirus, global outbreak, medical industry, medical industry action, coronavirus crisis, SARS-CoV-19, epidemic, FDA, FDA Emergency Use Authorization, EUA, FDA EUAComment