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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- June 28, 2022: FDA Roundup including authorization of an extension to the shelf-life of the refrigerated AstraZeneca monoclonal antibody, Evusheld, which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Consumers concerned about COVID-19 should consult with their health care provider.
- June 28, 2022: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
- June 28, 2022: Shelf-Life Extension of Evusheld under Emergency Use Authorization
- June 27, 2022: 2021 Office of New Drugs Annual Report (PDF), including efforts during the second year of the COVID-19 pandemic, specifically related to trial designs for COVID-19 therapies, collaboration with drug sponsors, and issuance of guidances addressing the impact of emergent variants on drug development.
- June 27, 2022: FDA Authorizes Shelf-Life Extension for REGEN-COV From 24 months to 30 Months
- June 24, 2022: FDA Roundup including announcement of an upcoming public meeting to discuss pulse oximeter accuracy and limitations
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
COVID-19 testing update
At-home COVID-19 test information and FAQs now available in Spanish
Medical countermeasure update
HHS expanding monkeypox testing capacity to five commercial laboratory companies
Last week, the Department of Health and Human Services (HHS), through the Centers for Disease Control and Prevention (CDC), began shipping FDA-cleared orthopoxvirus tests to five commercial laboratory companies, including some of the nation’s largest reference laboratories, to quickly increase monkeypox testing capacity and access in every community during the ongoing monkeypox outbreak.
Since the United States detected its first case, FDA has worked with commercial laboratories and manufacturers to make monkeypox testing more readily available to patients and providers who need tests. FDA is working closely with CDC to increase production of its FDA-cleared test. FDA has cleared CDC's test for distribution beyond the current Laboratory Response Network and has also cleared the use of additional reagents and automation to increase the testing capacity of laboratories using the CDC test. CDC has also published the testing protocol (PDF) from their FDA-cleared orthopoxvirus test for any interested laboratory to use to begin testing for monkeypox. FDA is currently exercising enforcement discretion with respect to laboratory developed tests (LDTs), such as those developed by hospitals or academic laboratories. (June 28, 2022)
Advanced manufacturing update
An FDA self-audit of continuous manufacturing for drug products
Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER’s Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval. (June 28, 2022) More about advanced manufacturing at FDA
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of June 28, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,016 revisions to test EUAs. Also see: COVID-19 Test Basics
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 Events
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June 29, 2022: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series on July 27 and August 24, 2022.
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July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. Registration is now open for in-person and virtual attendance. Last chance to register! Pre-registration is requested by June 30, 2022.
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July 14, 2022: FDA Grand Rounds: One Health at FDA: From Concept to Application, 12:00 - 1:00 p.m. ET, presented by CAPT Brianna Skinner, DVM, MPH, DACLAM, of FDA's Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia, DVM, of FDA's Center for Veterinary Medicine (CVM).
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New! August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - CVM will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
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Information for industry and health care providers
Expiration date extension: Evusheld
FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here) and, as required by the EUA for Evusheld, unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. FDA granted this extension following a thorough review of data submitted by AstraZeneca. 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). (June 28, 2022)
Expiration date extension: REGEN-COV
FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV (see Table 1, Table 2, and Table 3 here). Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the EUA Letter of Authorization (PDF). (June 27, 2022)
Draft guidance: Considerations for Rescinding Breakthrough Therapy Designation
On June 23, 2022, FDA issued a draft guidance to explain how FDA may consider whether to rescind a breakthrough therapy designation during evaluation of a drug or biologic development program. Submit comments by August 23, 2022.
Reminder: Information for health care providers about the authorization of Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age
On June 17, 2022, FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age. New and updated materials for health care providers include PDF wall charts (Moderna, Pfizer-BioNTech), Dear Healthcare Provider letters, and updated fact sheets. Additional information, including information about FDA's evaluation of safety and effectiveness, and ongoing safety monitoring, can be found in the press release.
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
Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 300 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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