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Coronavirus Disease 2019 (COVID-19) updates
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Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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Multilingual COVID-19 resources
 The FDA’s COVID-19-related consumer updates are now available in at least five languages. Don't miss these updates, all available in English, Spanish, Simplified Chinese, Korean, Tagalog, and Vietnamese.
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Emergency Use Authorization (EUA) updates
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Guidance update: Investigational COVID-19 Convalescent Plasma
The FDA updated its guidance, Investigational COVID-19 Convalescent Plasma, to provide additional information related to the recently issued EUA for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, Recommendations for Investigational COVID-19 Convalescent Plasma, which also provides this information. (September 2, 2020)
Diagnostic test EUAs
To date, the FDA has currently authorized 243 tests under EUAs; these include 195 molecular tests, 44 antibody tests, and 4 antigen tests. Also see: Coronavirus Testing Basics
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Events
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Today! September 9, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. FDA will host additional town halls in this series on Wednesdays in September. To ensure you are connected, please dial-in at 12:00 p.m.
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September 10, 2020: FDA Grand Rounds webcast: Advancing the Science of Real-World Data to Address the COVID-19 Pandemic, presented Amy P. Abernethy, MD, PhD, FDA Principal Deputy Commissioner and Acting Chief Information Officer, 12:00 - 1:00 p.m. ET, CE credit available
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September 15, 2020: Save the date for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
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New! September 17, 2020: Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities, a virtual symposium hosted by the HHS Office of Minority Health
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September 17-18, 2020: Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines - virtual workshop - agenda (PDF)
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October 2, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 Southern Hemisphere influenza season, which is part of FDA’s year-round efforts to flight flu, along with other public health partners like CDC and NIH.
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October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.
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Information for industry
The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 50 COVID-19-related guidances to date.
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In case you missed it
FDA Insight podcast: The opioid epidemic and COVID-19
Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, welcomes Megan Moncur, Associate Director of Opioid Policy, to the show to discuss the opioid epidemic and how it has been impacted by the COVID-19 pandemic.
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COVID-19 resources for health professionals
Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), resources to share with your patients, and more.
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FDA updates on hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 150 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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