|
Coronavirus Disease 2019 (COVID-19) updates
|
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- November 3, 2020: COVID-19 Update including two health fraud warning letters, an alert that false positive results can occur with antigen tests for the rapid detection of SARS-CoV-2, and more
- November 1, 2020: Remarks for the Global Pharmaceutical Manufacturing Leadership Forum, by FDA Commissioner Stephen M. Hahn, MD (with video, 14 minutes)
- October 30, 2020: COVID-19 Update including a consumer update on pulse oximeters and oxygen concentrators
- October 28, 2020: COVID-19 Update including an immediately in effect guidance, approval of two generic muscle relaxation drugs, and several warning letters
- October 30, 2020: FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
- October 27, 2020: A new Drugs Trials Snapshot is available for Veklury (remdesivir)
Bookmark www.fda.gov/coronavirus for the latest.
|
|
 |
|
|
 Pulse oximeters and oxygen concentrators: What to know about at-home oxygen therapy
Giving yourself too much or too little oxygen can be dangerous. If you are using a pulse oximeter to monitor your oxygen levels and think they are low, see a doctor. You should not use an oxygen concentrator at home unless it has been prescribed by a health care provider.
FDA publishes list of essential medicines, medical countermeasures, critical inputs required by executive order
As the FDA continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
The goal of this work is to ensure the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats. To accomplish this goal, the executive order seeks to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on foreign manufacturers of these products.
Over the past several weeks, the FDA has worked, in consultation with other federal partners, to develop a list of 223 drug and biological product essential medicines and medical countermeasures. Additionally, 96 device medical countermeasures are included on the list. These devices include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery and devices for management of acute illnesses such as ventilators, among others. Read more in the FDA press release (October 30, 2020)
|
|
Emergency Use Authorization (EUA) updates
|
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
FDA is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. The FDA is aware of reports of false positive results associated with antigen tests used in nursing homes and other settings. The FDA continues to monitor and evaluate these reports and other available information about device safety and performance.
The FDA reminds clinical laboratory staff and health care providers about the risk of false positive results with all laboratory tests. These are expected, especially when tests are used for screening in large populations with a low prevalence of infection. Clinical laboratory staff and health care providers can help ensure the accuracy of test results by closely following the authorized instructions for use of a test as well as key steps in the testing process as recommended by the Centers for Disease Control and Prevention (CDC). (November 3, 2020)
Diagnostic test EUAs
As of today, 287 tests are authorized by FDA under EUAs; these include 223 molecular tests, 57 antibody tests, and 7 antigen tests Also see: Coronavirus Testing Basics
|
|
 |
|
|
Events
-
Today! November 4, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - FDA will host a virtual Town Hall for SARS-CoV-2 test developers, 12:15 p.m. - 1:15 p.m. ET. To ensure you are connected, please dial-in at 12:00 p.m. ET. Additional webinars in this series will be held in 2020 on November 18, and December 2, 9, and 16.
-
New! November 6, 2020: Office of New Drug (OND) Research: Seeking Collaborators; Funding Opportunities Available - webinar, 1:00 - 2:30 p.m. ET - Includes an overview of OND’s Combatting Antibiotic-Resistant Bacteria (CARB) and 21st Century Cures Drug Development Tools Grant programs
-
November 12, 2020: FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? (webcast) - 12:00 - 1:00 p.m. ET - Please register in advance.
-
November 16, 2020: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs (virtual) - Register by November 12, 2020.
-
November 17, 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.
|
|
Information for industry
FDA updates policy on non-invasive remote monitoring devices used to support patient monitoring during COVID-19
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 60 COVID-19-related guidances to date.
|
|
In case you missed it
COVID-19 Vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
|
FDA Insight podcast: Get Your Flu Vaccine
Hear from Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, why it's more important than ever to get your seasonal flu vaccine this year.
|
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 200 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.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
