FDA Roundup: November 18, 2022

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Nov 18, 2022, 16:49 ET

SILVER SPRING, Md., Nov. 18, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Yesterday, the FDA provided an update on the Philips Respironics (Philips) June 2021 recall. Philips has informed the FDA that the Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues. The FDA has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers and health care professionals.
Yesterday, the FDA published the FDA Voices: "FDA's Cybersecurity Modernization Action Plan," by Vid Desai, Chief Information Officer and Craig Taylor, Chief Information Security Officer. The FDA's Cybersecurity Modernization Action Plan (CMAP) is a proposed framework and actionable recommendations for protecting the agency's infrastructure and data in today's environment of increased cybersecurity threats. The FDA will identify, prioritize and validate cybersecurity governance, standards and solutions to support the secure adoption of emerging technologies, such as Zero Trust and digital transformation, across the agency. CMAP will strengthen the agency's ability to protect sensitive information, modernize cybersecurity capabilities and improve operational situational awareness to decrease overall security risks.
Yesterday, the FDA issued an emergency use authorization for the Hotgen COVID-19 Antigen Home Test, an over-the-counter (OTC) COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first 7 days of experiencing COVID-19 symptoms or for individuals without symptoms. The test should be repeated if a negative result is found – at least twice over 3 days with at least 48 hours between tests if the individual has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the individual does not have symptoms. The test 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.
Yesterday, the FDA issued an emergency use authorization for the NIDS COVID-19 Antigen Home Test, where validation data were gathered through the FDA's collaboration with the National Institutes of Health Independent Test Assessment Program. The NIDS COVID-19 Antigen Home Test is an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first 5 days of experiencing COVID-19 symptoms or for individuals without symptoms. The test should be repeated if a negative result is found – at least twice over 3 days with at least 48 hours between tests if the individual has symptoms, or at least 3 times over 5 days with at least 48 hours between tests if the individual does not have symptoms. The test 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.
Yesterday, the FDA updated its Automated External Defibrillators (AED) web page to include:

Lists of FDA-approved AED and AED accessories
Actions you can take to help ensure you are purchasing FDA-approved AEDs and AED accessories
A summary of the FDA's continued efforts to keep AEDs and AED accessories safe and reliable, including requirements for premarket approval
The Consumer Update How AEDs in Public Places Can Restart Hearts was also updated.

On Wednesday, the FDA published the FDA Voices: "Focusing on Prevention to Safeguard Infant Formula," by Susan T. Mayne, Ph.D., Director, Center for Food Safety and Nutrition. The FDA continues to work with infant formula manufacturers to maximize production to fill shelves, and we have taken steps to allow for safe and nutritious infant formulas that were not previously in the U.S. market to enter, adding greater resilience to the infant formula supply chain. Beyond our focus on increasing supply, the FDA is taking additional steps to assure the public that infant formula is and will remain safe.
On Wednesday, the FDA published tips for buying medicines online safely. How can you tell if an online pharmacy is operating legally? The FDA's BeSafeRx site can help you identify and avoid dangerous online pharmacies.
On Wednesday, the FDA published a new report, Successes and Opportunities in Modeling & Simulation for FDA. Computational modeling and simulation are powerful tools that complement traditional methods for gathering evidence about products regulated by the FDA. FDA scientists routinely review results from M&S studies submitted by industry and use M&S approaches for scientific research and regulatory decision-making. This report presents a selection of modeling and simulation case studies from across the FDA, illustrating how these technologies are playing an important role in helping the agency protect and promote public health.
On Wednesday, the FDA completed its first pre-market consultation for a human food made from cultured animal cells. We evaluated the information UPSIDE Foods submitted to the agency and have no further questions at this time about the firm's safety conclusion. The firm will use animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food. The voluntary pre-market consultation is not an approval process. Instead, it means that after our careful evaluation of the data and information shared by the firm, we have no further questions at this time about the firm's safety conclusion. Before entering the U.S. market, the food must meet other federal requirements.
On Wednesday, the FDA announced the availability of a draft amended Environmental Assessment (EA) for an approved application concerning Atlantic salmon with an intentionally altered genome (known as AquAdvantage Salmon, or AAS), and a subsequent virtual public meeting to obtain public input on the draft amended EA. The FDA approved an application concerning AAS on November 19, 2015. In the draft amended EA, the FDA has expanded its assessment beyond that in the 2015 EA to include an exhaustive analysis of the likelihood and severity of harms that could occur in the highly unlikely event that AAS or their broodstock were to escape confinement, migrate from Canada to the U.S., and be present in the U.S. aquatic environment. To attend or provide comment at the meeting, please register in advance.
On Wednesday, the FDA approved Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Rezvoglar may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in your blood) and heart failure. For more information on Rezvoglar, including instructions for use and the risks and associated adverse reactions, read the prescribing information.
On Tuesday, in collaboration with FDA, MITRE updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact device functions.

Updates to the playbook include:

Emphasizing the need to have a diverse team participating in cybersecurity preparedness and response exercises – including clinicians, health care technology management professionals, IT, emergency response, risk management and facilities staff.
Highlighting considerations for widespread impacts and extended downtimes during cybersecurity incidents which benefit from the use of regional response models and partners.
Adding a resource appendix making it easier to find tools, references and other resources to help health care organizations prepare for and respond to medical device cybersecurity incidents (including ransomware).

The FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. The FDA BAA is open to all responsible sources and small businesses are strongly encouraged to respond. Offerors may include single entities or teams from private sector organizations, Federally Funded Research and Development Centers (FFRDCs) and academic institutions. Prospective applicants are invited to join us for FDA BAA Day on Dec. 6, 2022, to learn more about the FY 2023 BAA solicitation, including areas of interest and how to apply for funding. A draft agenda is now available. To attend, please register in advance.
COVID-19 testing updates:

As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests and four molecular OTC at-home tests.
The FDA has authorized 35 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1,161 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration