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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- February 28, 2023: FDA Roundup including an invitation to attend the March 9, 2023, Grand Rounds on Microphysiological Systems as Novel Disease Models and Drug Development Tools
- February 27, 2023: FDA's Center for Drug Evaluation and Research (CDER) Division of Applied Regulatory Science published its 2022 Annual Report (PDF), including COVID-19 research
- February 24, 2023: FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses
- February 24, 2023: FDA Roundup including authorization of two new COVID-19 OTC antigen at-home tests
- February 22, 2023: FDA announced an April 25, 2023, virtual Public Meeting on Patient-Focused Drug Development for Long COVID, with live translation in both English and Spanish
- February 21, 2023: Update: FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination - FDA is also now warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.
- February 21, 2023: Hand sanitizer recall: nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution - Certain batches of this product may exceed FDA limits for methanol.
Quick links: COVID-19 updates from FDA, FDA Mpox Response
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COVID-19 testing updates
FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses
FDA issued an EUA (PDF) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. (February 24, 2023)
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FDA issues EUAs for two new COVID-19 OTC antigen at-home tests
FDA recently issued Emergency Use Authorizations (EUAs) for two additional over-the-counter (OTC) at-home COVID-19 antigen tests: the GenBody COVID-19 Ag Home Test (PDF, manufactured by GenBody, Inc.), and the COVI-Go SARS-CoV-2 Ag Self-Test (PDF, manufactured by Mologic, Inc.). Validation data to support authorization of these tests were gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between FDA and NIH.
Both tests can be used for serial testing for symptomatic people within the first 5 days of symptom onset or for people who do not have symptoms. The GenBOdy COVID-19 Ag Home Test shows results in 15 minutes, and the COVI-Go-SARS-CoV-2 Ag Self Test shows results in 20 minutes. These tests should always be repeated if a negative result is found—at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms. The tests can be used for people age 14 years or older with a self-collected nasal swab sample and age 2 years or older when an adult collects the nasal swab sample. Learn more (February 24, 2023)
Public health lawyers: Join FDA!
Job opening: Regulatory Counsel (Title 21, Cures Band C)
Apply to join the FDA Office of Counterterrorism and Emerging Threats (OCET) in the position of Regulatory Counsel, offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. For more information, see the job posting (PDF). Applications are due by March 15, 2023 (deadline extended)..
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Emergency Use Authorization (EUA) updates
COVID-19 in vitro diagnostic (test) EUAs
As of February 28, 2023, 444 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and 1 diagnostic breath test. There are 78 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, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 45 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,257 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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February 28-March 1, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of two respiratory syncytial virus (RSV) vaccine Biologics License Applications (BLAs).
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March 7, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2023-2024 influenza season.
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March 9, 2023: FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools - This presentation by researchers from FDA's National Center for Toxicological Research (NCTR) evaluates a testicular organoid model for use as an in vitro model of Zika virus infection.
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New! March 14, 2023: FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop (virtual) - To discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products.
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New! March 16, 2023: Antimicrobial Drugs Advisory Committee Meeting (virtual) - The committee will meet in open session to discuss a New Drug Application (NDA) for Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) for oral use. The proposed indication is treatment of mild-to-moderate coronavirus disease (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is currently authorized for emergency use.
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March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual)
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New! March 30, 2023: Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation Public Workshop (virtual) - Immune globulins (IGs) are used extensively to treat primary and secondary antibody deficiencies, and a variety of autoimmune diseases. The purpose of the workshop is to gain insight and to identify measures to prevent hypersensitivity reactions associated with specific lots of IG.
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April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities, including hands-on training for in-person attendees. Registration is now open. In-person pre-registration closes March 10, 2023 (space is limited), and virtual pre-registration closes April 14, 2023.
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New! April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - To provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial. This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
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Information for industry and health care providers
Mpox response update: TPOXX shelf-life extension
In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children.
The safety and efficacy of TPOXX for the treatment of human mpox has not been established. In September 2022, the National Institute of Allergy and Infectious Diseases opened a randomized, controlled clinical trial to assess the safety and efficacy of TPOXX for the treatment of mpox infection. Health care providers should encourage their patients with mpox infection to be evaluated for enrollment in this trial. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDC’s expanded access protocol (EA-IND) should be consistent with CDC’s guidelines for tecovirimat use.
On February 3, 2023, FDA approved a shelf-life extension of TPOXX (tecovirimat) Injection, 200 mg, from 24 months to 42 months for some lots of TPOXX injection. TPOXX supplied by the Strategic National Stockpile (SNS) does not have an expiration date printed on its label. To determine the expiration date for product received from the SNS, find the lot number on the product label and refer to this table to identify the corresponding expiration date. (February 22, 2023)
Breakthrough Devices Program adds more device designations and marketing authorizations
FDA's Breakthrough Devices Program can help provide patients and health care providers with timely access to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Additionally, the program enhances partnerships with manufacturers where they can interact with the FDA’s experts to receive feedback on device development, receive help navigating the path to the FDA’s marketing authorization, and obtain prioritized review on regulatory submissions. FDA updated the list to add additional device designations and marketing authorizations. (February 24, 2023)
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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.
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In case you missed it
MCMi FY 2022 Program Update
In February, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report for fiscal year 2022, which showcases FDA's work each year to prepare for all types of public health emergencies. Download a printable PDF.
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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.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 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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FDA Medical Countermeasures Initiative (MCMi) News)
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