FDA Roundup: December 9, 2022

SILVER SPRING, Md., Dec. 9, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA, in coordination with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention, collaborated with the Conference of Food Protection to release food safety best practices for third-party delivery services. These recommendations focus on key parameters companies should consider when delivering food to consumers.
  
  
• On Thursday, the FDA approved the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Bexacat (bexagliflozin tablets) is also the first sodium-glucose cotransporter 2 (SGLT2) inhibitor new animal drug approved by the FDA in any animal species. An SGLT2 inhibitor is not insulin and is not for use in cats with the type of diabetes mellitus that requires insulin treatment. The labeling for Bexacat includes a boxed warning regarding the critical need for appropriate patient selection and the potential for certain severe adverse reactions.
  
  
• On Thursday, the FDA provided information and resources for consumers about the different types of non-invasive body contouring technologies, sometimes referred to as body sculpting, the risks associated with devices, and how to report a problem with or after the use of any medical device. The FDA encourages people to:
• Talk with your health care provider about the benefits and risks associated with body contouring devices. All body contouring devices can cause complications that may be temporary, but some are serious and could last longer, become permanent, or may require surgery to correct.
• Understand that not everyone responds to body contouring or achieves their desired effect, some results may be temporary, and you may need more than one treatment.
• Know that non-invasive body contouring is not intended to treat obesity or to improve your health.
• Read any available patient brochures to understand the risks and whether the effect you are seeking is reasonable. Talk with your health care provider if you have additional questions and about which procedures may be best for you.
  
  
• On Wednesday, the FDA released the results of the agency's 2022 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. Asbestos was not detected in any of the 50 samples tested in 2022. The testing was conducted using Polarized Light Microscopy and Transmission Electron Microscopy.
  
  
• On Wednesday, the FDA approved an expansion of the indications for use for the Endomagnetics Ltd. Magtrace and Sentimag Magnetic Localization System to use in patients with breast cancer undergoing mastectomy or lumpectomy. The system uses an injection of a tracing agent, Magtrace, to assist in sentinel lymph node biopsies, which are used to determine whether the cancer has spread beyond the initial tumor. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, the tracing agent is intended only for injection around the tumor.
  
  
• On Tuesday, the FDA issued an Emergency Use Authorization (EUA) for the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit – a test kit supported by the U.S. Government through the Biomedical Advanced Research and Development Authority (BARDA). The Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection, and should not be used to diagnose or exclude an acute SARS-CoV-2 infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Antibodies to COVID-19 are generally detectable in blood several days after initial infection, although the duration of time neutralizing antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following infection. Negative results do not preclude acute COVID-19 infection, and if acute infection is suspected, direct testing for COVID-19 is necessary. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet the requirements to perform high or moderate complexity tests.
  
  
• COVID-19 testing updates:
• As of today, 440 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 86 antibody and other immune response tests, 55 antigen tests, and 1 diagnostic breath test. There are 79 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, 23 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
• The FDA has authorized 39 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1169 revisions to EUA authorizations

 Additional Resources: 

• FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540 

Consumer Inquiries: 888-INFO-FDA 

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