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Coronavirus Disease 2019 (COVID-19) updates
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Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- December 28, 2020: COVID-19 Update including an updated letter of authorization, health care provider fact sheet, and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, and an update to the Device Shortage List
- December 22, 2020: COVID-19 Update including translations of the Moderna COVID-19 Vaccine fact sheet in multiple languages, and new abbreviated new drug application (ANDA) approvals
- December 21, 2020: COVID-19 Update including translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet in multiple languages, and a new guidance
Bookmark www.fda.gov/coronavirus for the latest.
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Additional information about the Pfizer-BioNTech COVID-19 vaccine
FDA posted an updated letter of authorization, health care provider fact sheet, and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial. These updates are consistent with previous FDA advice that it would be acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since the vaccine does not contain preservative, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.(December 23, 2020)
Translations of the Pfizer-BioNTech vaccine fact sheet for recipients and caregivers are now available in 20+ languages.
Additional information about the Moderna COVID-19 vaccine
FDA posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations. (December 21, 2020)
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Emergency Use Authorization (EUA) updates
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Diagnostic test EUAs
As of today, 309 tests and sample collection devices are authorized by FDA under EUAs. These include 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics
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Events
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January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. CE credit available.
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New! February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials (remote only) - The Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, is convening this public webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials.
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Information for industry
Medical device shortages during the COVID-19 public health emergency
On December 23, 2020, FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, FDA added the following device types in the testing supplies and equipment category:
- Pipette tips (product codes LXG and PPM)
- Micro pipettes (product code JRC)
FDA also added clarifying notes and links to more resources in the "Additional Information" column, as well as adding clarity to the categories, such as grouping gloves under "Personal Protective Equipment - Gloves."
The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the lists as the COVID-19 public health emergency evolves. Also see: Supplies of Medical Devices for COVID-19: Frequently Asked Questions
Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency
- FDA issued a temporary guidance explaining how the agency will determine review timelines following issuance of a complete response letter when a facility assessment is necessary for FDA’s regulatory decision on an original or supplement application. The guidance applies to inspections of manufacturing facilities and also bioresearch monitoring (BIMO) program sites conducting clinical, analytical, and nonclinical studies.
Reminder: FDA funding opportunity: FY 2021
- Extramural medical countermeasure (MCM) regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Proposers are encouraged to submit white papers by January 28, 2021 for FY 2021 award consideration. For more information, including examples of previously funded projects, see MCMi Extramural Research.
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 65 COVID-19-related guidances to date.
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In case you missed it
COVID-19 vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 220 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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