COVID-19 Treatments: Remdesivir Antiviral Drug

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences, for treating COVID-19 patients needing acute care in a hospital. This treatment was available until now under an Emergency Use Authorization (EUA), but a full FDA approval will facilitate broader use.

Industry NewsNaveen AgarwalOctober 26, 2020covid-19 treatments, COVID-19, covid-19, coronavirus crisis, coronavirus pandemic, FDA, Remdesivir, antibody cocktailComment

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

5 Key Facts to Know About FDA’s Emergency Use Authorization Process

The current COVID-19 global pandemic continues to remain out of control. As we write this blog, over 60,000 new infections are being reported on a daily basis in the United States, with a cumulative total of over 4 million cases and over 150,000 deaths reported since the pandemic first began here.

Regulatory NewsNaveen AgarwalJuly 31, 2020COVID-19, FDA, FDA Emergency Use Authorization, medtechComment

COVID-19 Testing – Understanding Antibody Tests

There is a lot of conversation about testing. Antibody tests, also called serological tests, help detect the presence of antibodies in blood samples. Antibody testing, when done at large scale, can help us understand the true rates of infection, mortality rates and level of immunity in the population on a regional basis. That is why these tests are a very powerful tool to help fight this devastating disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 20, 2020covid-19, COVID-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulations, FDA approves coronavirus tests, antibody tests, serological testsComment

FDA Guidance for Face Shields and Respirators During the Covid-19 Pandemic

The medical landscape is constantly changing, particularly during the COVID-19 pandemic. With so much happening, there is a lot of confusion, particularly surrounding shortages of Personal Protective Equipment (PPE) and Face Masks. The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. In this article, we will cover Face Shields and Respirators.

Industry News, Regulatory NewsNaveen AgarwalJuly 10, 2020COVID-19, covid-19, coronavirus criss, coronavirus crisis, coronavirus pandemic, FDA, FDA regulation, FDA authorization, FDA News, respirators, N95 masks, face shields, face masksComment

FDA Guidance for Face Masks During Covid-19 Pandemic

Since the onset of the COVID-19 pandemic, there has been a lot of conversation surrounding the shortages of Personal Protective Equipment (PPE). In particular, we hear a lot about face masks and how they can help prevent the spread of COVID-19. But there is a lot of confusion out there - and many strong opinions - both for and against the use of face masks! In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

Regulatory News, Industry NewsNaveen AgarwalJuly 6, 2020COVID-19, covid-19, sars-cov-2, coronavirus crisis, coronavirus pandemic, ppe, surgical masks, face masks, FDA regulation, FDA authorization, FDA guidanceComment

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

FDA Guidance Provides Relief for MDR Reporting During a Pandemic

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.

Regulatory ComplianceNaveen AgarwalMarch 22, 2020FDA guidance, MDR, MDR reporting, pandemic, coronavirus crisus, coronavirus pandemic, adverse event reporting, COVID-19, FDA reporting requirements, MDR reporting update, FDA Medical Device Reporting 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