FDA approves first fecal microbiota product | COVID-19 therapeutic EUA updates

If your email program has trouble displaying this email, view as a webpage.

The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include: December 6, 2022: FDA Roundup including a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure that these drugs meet standards for safety, effectiveness, and quality.  November 30, 2022: FDA Approves First Fecal Microbiota Product for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older November 30, 2022: FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region  Quick links: COVID-19 updates from FDA, FDA mpox Response

COVID-19 therapeutic updates

Bebtelovimab is not currently authorized in any U.S. region

FDA announced that bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1., according to data included in the EUA Fact Sheet for Healthcare Providers (PDF).

The CDC now estimates the combined proportion of COVID-19 cases caused by the omicron BQ.1 and BQ.1.1 variants to be above 50% nationally. Healthcare providers should use other approved or authorized products that are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients. (November 30, 2022) 

Emergency Use Authorization (EUA) updates

EUA revocations FDA revoked EUAs for these tests for the reasons noted in the revocation letters:  November 30, 2022: MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay (The University of Texas MD Anderson Cancer Center) December 2, 2022: Visby Medical COVID-19 (PDF) and Visby Medical COVID-19 Point of Care Test (PDF) (Visby Medical, Inc.) Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations. COVID-19 in vitro diagnostic (test) EUAs As of December 6, 2022, 441 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 55 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 39 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,169 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics

Events

• December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 (webinar) - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
• December 7-8, 2022: The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 (virtual public workshop) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation. 
• December 8, 2022: FDA Grand Rounds: Wastewater Surveillance for SARS-CoV-2 Variants: a pandemic response project leveraging FDA’s GenomeTrakr network - With funding from the American Rescue Plan Act, FDA scientists leveraged an existing laboratory network normally tasked for foodborne pathogen surveillance to start sequencing SARS-CoV-2 from regional wastewater treatment plants across the U.S. New laboratory and analysis methods, public database structures, and FDA dashboard summarizing data collected were developed for this project.
• December 8, 2022: Blood Products Advisory Committee meeting (virtual) - The committee will meet in open session to hear an overview of the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
• December 14, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. 
• December 16, 2022: Machine Learning in Distributed Data Networks like the FDA Sentinel System: Opportunities, Challenges, and Considerations (12:30 - 1:30 p.m. ET, virtual)

Information for industry and health care providers

ICYMI: mpox antigen EUA templates for test developers FDA posted two new antigen EUA templates with recommendations on what to include in EUA requests or Pre-EUA submissions for antigen tests to detect the virus that causes mpox. (November 29, 2022) Reminder: On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.

Evusheld expiration date extension

FDA and HHS/ASPR authorized an additional extension to the shelf-life for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld, from 18 months to 30 months. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the EUA Letter of Authorization (PDF). (December 5, 2022)

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

Update your antibodies The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.

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. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)

Expiration date extensions of COVID-19 at-home tests Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 350 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)