FDA Suspends Inspections Outside of the US Due to Coronavirus Outbreak

FDA is suspending its inspections outside of the US through April in response to the coronavirus (COVID-19) pandemic. Inspections outside of the U.S. would be deemed “mission-critical” and would be considered on a case-by-case basis. The measure would be effective immediately. In a release, FDA Commissioner Stephen Hahn, MD said, “We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.” FDA said it based this decision on several different factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees; Centers for Disease Control and Prevention travel recommendations; access restrictions being imposed on foreign visitors by certain countries; guidance from the Office of Personnel Management; and the importance of the health and safety of its employees. The agency has taken measures and worked to get out in front of coronavirus. In late January, FDA laid out a multi-pronged strategy to handle any potential coronavirus outbreaks. Early last month, FDA granted EUA for the Centers for Disease Control and Prevention’s Coronavirus dete...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Food & Agriculture Headlines Health Poverty & SDGs Coronavirus Source Type: news
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Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news
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Source: Viruses - Category: Virology Authors: Tags: Review Source Type: research
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Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: General Grief and Loss Health-related Mental Health and Wellness Policy and Advocacy coronavirus COVID-19 Source Type: blogs
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Source: Nature Podcast - Category: Science Authors: Source Type: podcasts
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Source: The Medical Futurist - Category: Information Technology Authors: Tags: Network medicine Artificial Intelligence Biotechnology Telemedicine & Smartphones AI MIT coronavirus covid covid19 vaccine research pandemic network science Albert-László Barabási Source Type: blogs
This article is protected by copyright. All rights reserved. PMID: 32438473 [PubMed - as supplied by publisher]
Source: European Journal of Immunology - Category: Allergy & Immunology Authors: Tags: Eur J Immunol Source Type: research
This article is protected by copyright. All rights reserved. PMID: 32437587 [PubMed - as supplied by publisher]
Source: European Journal of Immunology - Category: Allergy & Immunology Authors: Tags: Eur J Immunol Source Type: research
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Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Aid Development & Aid Featured Global Headlines Health Humanitarian Emergencies IPS UN: Inside the Glasshouse Poverty & SDGs Regional Categories TerraViva United Nations COVID-19 World Health Assembly World Health Organisation (W Source Type: news
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