Coronavirus (COVID-19) Update: Daily Roundup April 30, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

Today, the FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to ...

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FDA Issues Guidance Highlighting Flexibility Under the Drug Supply Chain Security Act (DSCSA)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exemption-and-exclusion-certain-requirements-drug-supply-chain-security-act-during-covid-19-public?utm_campaign=FDA%20issues%20guidance%20highlighting%20flexibility%20under%20the%20DSCSA&utm_medium=email&utm_source=Eloqua
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FDA Issues Guidance Highlighting Flexibility Under the Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA) for trading partners responding to the COVID-19 public health emergency.

During the COVID-19 public health emergency, DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to the emergency distribution of prescription drugs issued an emergency use authorization to combat COVID-19 or approved by FDA to diagnose, cure, mitigate, treat or prevent COVID-19. Currently, there are no products approved by FDA to diagnose, cure, mitigate, treat or prevent COVID-19. Similarly, the DSCSA requirements described in the guidance do not apply in certain circumstances to products used for emergency medical reasons such as supportive care for COVID-19 patients, where distribution of such products is directly affected by the COVID-19 public health emergency.

This legal flexibility, triggered by emergency medical needs such as addressing the COVID-19 public health emergency, strikes a balance between the need to effectively distribute prescription drugs under emergency conditions and helping protect consumers from exposure to prescription drugs that may be counterfeit, stolen or otherwise harmful.

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Photo album captures touching moments in China's COVID-19 fight - Chinadaily.com.cn

Photo album captures touching moments in China's COVID-19 fight

By Ma Chi | chinadaily.com.cn | Updated: 2020-04-30 10:50

X-ray database could be key to virus fight - World - Chinadaily.com.cn

X-ray database could be key to virus fight - World - Chinadaily.com.cn

No hay ninguna descripción de la foto disponible.

X-ray database could be key to virus fight

By ANGUS McNEICE | China Daily Global | Updated: 2020-04-28 09:26

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