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.
Read MoreRecently, 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.
Read MoreThere 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.
Read MoreThe 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.
Read MoreSince 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.
Read MoreTimely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.
Read MoreIndustry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.
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