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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- November 1, 2022: FDA Roundup including a safety communication to alert patients, caregivers, and health care providers about a shortage of tracheostomy tubes
- November 1, 2022: FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. More below, under EUA updates
- October 31, 2022: FDA launched a new web-based application for single-patient emergency use IND requests for Tembexa, a therapeutic option for patients with human monkeypox disease who meet specific eligibility criteria.
- October 28, 2022: FDA Roundup including an FDA Voices: FDA Continues to Advance Medicines for Children
Quick links: COVID-19 updates from FDA, FDA Monkeypox Response
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COVID-19 vaccine updates
Monkeypox response updates
New eIND process for Tembexa
FDA launched a new web-based application for single-patient emergency use IND requests for Tembexa, a therapeutic option for patients with human monkeypox disease who meet specific eligibility criteria. Additional information about Tembexa is available at FDA Monkeypox Response: Therapeutics. (October 31, 2022)
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Emergency Use Authorization (EUA) updates
COVID-19 antigen tests: EUA revision for repeat testing
FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. The letter eliminates one Condition of Authorization that is no longer needed.
This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others.
The EUA revision requires test developers in the scope of the revision to update product labeling to include the revised authorized uses:
- Repeat testing at least 2 times over 3 days with at least 48 hours between tests for people with COVID-19 symptoms.
- Repeat testing at least 3 times over 5 days with at least 48 hours between tests for people without COVID-19 symptoms.
If you have questions about this EUA revision, please email COVID19DX@fda.hhs.gov. Read more: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 (November 1, 2022)
COVID-19 in vitro diagnostic (test) EUAs
As of November 1, 2022, 435 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 77 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,145 revisions to EUA authorizations. Also see: COVID-19 Test Basics
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Events
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November 9, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee (virtual, 9:00 a.m. - 5:00 p.m. ET) - The committee will discuss the request for EUA 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
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November 9, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (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. The November 9 event will cover the topic of monkeypox only. FDA will hold additional events in this series on November 30 and December 14, 2022.
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New! November 8, 2022: Maximizing Benefits and Minimizing Harms from Antibiotics: Scientific, Regulatory and Clinical Considerations by Dr. Sara Cosgrove (webcast, 3:00 - 4:00 p.m. ET), hosted by the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation (CERSI). Please register in advance.
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New! November 15, 2022: Virtual Public Workshop - CDRH Industry Basics: Understanding Risk with Medical Devices (virtual, 1:00 - 3:00 p.m. ET) - The workshop will expand on the basics of risk with medical device use by featuring Risk Basics for Medical Devices and Application of Risk Management Principles for Medical Devices. Participants may choose one or both sessions. No registration required.
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November 15-16, 2022: 14th Annual Sentinel Initiative Public Workshop (virtual) - Hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, participants will hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic and monkeypox public health emergency.
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November 17, 2022: FDA Grand Rounds - Medical Extended Reality: Applications and Challenges (webcast, 12:00 - 1:00 p.m. ET) - FDA Physicist and CDRH Office of Science and Engineering Laboratories (OSEL) Medical Extended Reality (MXR) Program Coordinator Ryan Beams, Ph.D., will present an overview of augmented and virtual reality technology and of the landscape of potential medical applications. He will also discuss regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
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December 6, 2022: Save the date for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply. Registration is now open.
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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.
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New! 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.
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Information for industry and health care providers
New changes to FAQ on testing for COVID-19
FDA updated the answer to the question, "I am developing a COVID-19 diagnostic test. How can I obtain appropriate test materials for assay validation?" at FAQs on Testing for SARS-CoV-2. (October 28, 2022)
CMC Development and Readiness Pilot (CDRP) Program
FDA announced a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. As described in the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. For sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, to include two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on readiness and defined CMC milestones. (October 31, 2022)
Guidance: Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
FDA announced the availability of a revised draft guidance for industry entitled Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers. Since 2017, FDA has received many questions concerning implementation of the regulatory requirements of the expanded access program. In addition, FDA developed recommendations for fulfilling the new requirements for expanded access submissions promulgated in the 21st Century Cures Act (2016) and the FDA Reauthorization Act of 2017 (FDARA). FDA is providing this guidance in a question-and-answer format, addressing the most recent frequently asked questions and sharing recommendations to fulfill the new statutory requirements. This guidance revises the guidance of the same title issued in June 2016 and updated in October 2017. Submit comments by January 3, 2023. (November 1, 2022)
Reminder: COVID-19 health care professional resources
Bookmark our updated web page for the latest COVID-19 news for health care professionals, including safety alerts, and information about medical countermeasures and shortages. (October 18, 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.
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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. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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Update your antibodies
The virus that causes COVID-19 changes over time. Keep your protection against COVID-19 up to date by getting a bivalent COVID-19 vaccine booster dose. 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 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.
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FDA Medical Countermeasures Initiative (MCMi) News)
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