| 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: Bookmark www.fda.gov/coronavirus for the latest. | | |  Know your treatment options for COVID-19 Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19. Here's a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19. Your provider will know the best option for you, based on your symptoms, risks, and health history. COVID-19 vaccine updates Janssen COVID-19 Vaccine information in multiple languages Janssen COVID-19 Vaccine fact sheets for recipients and caregivers are now available in multiple languages. Additional languages will be posted to the Janssen COVID-19 Vaccine page as they become available. Related information: | | Emergency Use Authorization (EUA) updates  FDA launches new COVID-19 EUA FAERS Public Dashboard FDA launched an important update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard. The FAERS Public Dashboard is a user-friendly search tool that improves access to data on adverse events associated with the use of drug and therapeutic biological products submitted to FAERS. During public health emergencies, the FDA may issue EUAs to facilitate the availability and use of medical countermeasures. To expand access to adverse event safety data during the COVID-19 public health emergency, FDA has launched the COVID-19 EUA FAERS Public Dashboard. This dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under an EUA during the COVID-19 public health emergency. The COVID-19 EUA FAERS Public Dashboard was made available to the public to increase transparency and provide more efficient access to safety information. After launching the FAERS Public Dashboard, click on the COVID-19 EUA link at the top of the home page to open the COVID-19 EUA FAERS Public Dashboard. For more information on using the FAERS Public Dashboard and COVID-19 EUA FAERS Public Dashboard and to access, please visit the FAERS Public Dashboard page and the FAERS dashboard FAQ page. (March 15, 2021) Propofol EUA FDA issued an EUA (PDF) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet (PDF) for more information before administering it. (March 12, 2021) EUA templates FDA issued a new supplemental template (Word doc) for test developers seeking EUA of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. Read more (March 16, 2021) Diagnostic test EUAs As of today, 341 tests and sample collection devices are authorized by FDA under EUAs. These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests, and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test. Also see: Coronavirus Testing Basics | | | Events - Today! March 17, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on March 24 and 31, 2021.
- Today! March 17, 2021: House Committee on Energy & Commerce, Oversight & Investigations Subcommittee Hearing: Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations, with witnesses including Peter Marks, M.D., Ph.D., director, FDA Center for Biologics Evaluation & Research (CBER)
- New! March 18, 2021: Senate Health, Education, Labor, and Pensions Committee Hearing: Examining Our COVID-19 Response: An Update from Federal Officials, including Peter Marks, M.D., Ph.D., Director, FDA CBER
- May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year's keynote speaker is NIAID Director Anthony Fauci, MD.
| | Information for industry Potential for false results with Roche cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs -
Testing remains an important cornerstone of our nation's fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as whether an individual should participate in an activity, based on the test results. Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs. Our actions complement those taken by the Centers for Disease Control and Prevention (CDC) and are not intended to replace CDC's testing or other public health guidance. Read more, and see our new fact sheet, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs (March 16, 2021) 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 70 COVID-19-related guidances to date. | | In case you missed it  FDA is vigilant in protecting consumers against COVID-19 vaccine scams Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more |  List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 225 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. |  Why you should not use ivermectin to treat or prevent COVID-19 Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in Spanish, Portuguese, Simplified Chinese, Korean, Vietnamese and Tagalog. | Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
| | | | |
No comments:
Post a Comment