| 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. | | |  COVID-19 vaccine updates Multilingual COVID-19 vaccines myths social media toolkit FDA has created a new toolkit with Twitter, Facebook, and Instagram messages and images to help address common myths about the COVID-19 vaccines, and share the facts with your community. Messages and graphics are available for download in English, Spanish, Simplified Chinese, Korean, Tagalog, and Vietnamese. Data standards for Animal Rule studies FDA worked with the Clinical Data Interchange Standards Consortium (CDISC) to develop electronic data standards for the natural history and efficacy studies conducted in animals that support Animal Rule applications. The Standard for Exchange of Nonclinical Data (SEND) Implementation Guide-Animal Rule v1.0 (SENDIG-AR v1.0) was published by CDISC on September 17, 2019, and FDA's support for these data standards began on March 15, 2020. SEND data sets will be required in Animal Rule submissions to the Center for Drug Evaluation and Research (CDER) for studies initiated after either March 15, 2022, or March 15, 2023, depending on the type of regulatory submission. To learn more about the requirements for data standards for Animal Rule submissions to CDER, see FDA's Animal Rule Information web page. | | Emergency Use Authorization (EUA) updates  EUA templates for test developers FDA posted updated templates intended to assist test developers and facilitate the EUA request and Pre-EUA submission processes for COVID-19 tests. The following templates include updated recommendations and additional clarity for test developers: Diagnostic Templates (Molecular and Antigen) Serology/Antibody Templates These templates are intended to help test developers provide validation data and other information to the FDA. Developers can use alternative approaches and can discuss them with the FDA. Learn more: In Vitro Diagnostics EUAs (October 6, 2021) EUA of COVID-19 tests: Independent assessment of the FDA's response On October 12, 2021, FDA posted information about an assessment of the EUA process that the FDA's Center for Devices and Radiological Health (CDRH) implemented to help authorize COVID-19 tests during the public health emergency. The assessment was conducted by Booz Allen Hamilton, an independent, third-party contractor. This assessment focuses on how CDRH prioritized processing of EUA requests, review times, accuracy and reliability of COVID-19 tests, a comparison to prior public health emergencies, and requestors' perspectives. Sotrovimab EUA reissued On October 8, 2021, FDA reissued the EUA for Sotrovimab to reflect that the distribution of the authorized sotrovimab will be controlled by the United States Government. The letter of authorization (PDF) has also been revised to include an additional condition requiring healthcare facilities and providers to report therapeutics information and utilization data as directed by the U.S. Department of Health and Human Services. The Fact Sheet for Healthcare Providers (PDF) has also been revised to detail mandatory reporting of therapeutics information and utilization data. In vitro diagnostic (test) EUAs As of October 12, 2021, 416 tests and sample collection devices are authorized by FDA under EUAs. These include 291 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 36 antigen tests. There are 65 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 8 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 16 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 647 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics | | | Events - October 14-15, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - VRBPAC will discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or "mix and match" booster).
- October 20, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH).
- October 26, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet in open session to discuss Pfizer Inc.'s request to amend its EUA to allow for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
| | Information for industry and health care providers FDA withdrawing temporary guidances for alcohol-based hand sanitizers FDA announced that it intends to withdraw, effective December 31, 2021, guidance documents originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances, must no longer be sold to wholesalers or retailers by March 31, 2022. Also see: Q&A for Industry | Withdrawal of Temporary Hand Sanitizer Guidances (October 12, 2021) Did you know? You can find more information about COVID-19 and FDA-regulated products on these web pages: 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 75 COVID-19-related guidances to date. | | In case you missed it  It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. |  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 six additional languages.
|  List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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. |  Learn more about COVID-19 vaccines
Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines. | Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
| | | | |
No comments:
Post a Comment