FDA Roundup: December 16, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA released a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is a tool for assessing the risk of antimicrobial resistance in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003. 
• Updates to the guidance include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and a revised ranking of antimicrobial drug classes as critically important, highly important, or important based on the newly updated ranking criteria (Appendix A). Once FDA finalizes this revised draft GFI, the agency expects to reassess the rankings in Appendix A periodically to align with current science and clinical practices in human medicine. 
• The FDA will be accepting public comments on the draft guidance until March 20, 2023.
• Today, the FDA reminded manufacturers that effective January 1, 2023, foods containing sesame will be subject to specific food allergen regulatory requirements, including labeling and manufacturing requirements. Sesame is joining the list of major food allergens defined in the law as the result of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which was signed into law April 23, 2021. Sesame joins eight other major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
• On Wednesday, the FDA provided an easy step-by-step guide to help consumers decide when and how many times to test for COVID-19, what their test results mean and what they should do next. FDA-authorized over-the-counter (OTC) at-home COVID-19 tests for self-testing at home or other locations are a fast and convenient COVID-19 testing option. With the holiday season upon us and many indoor gatherings taking place, we hope this information will help guide consumers and their families through a safe and healthy holiday and beyond, especially with other respiratory infections circulating, including flu and RSV.
• On Wednesday, the FDA approved updated labeling for capecitabine tablets (Xeloda) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the first drug to receive a labeling update under this pilot program.
• Project Renewal is a collaborative program that involves external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation and evaluation of evidence for independent FDA review. It’s limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies and substantial post-marketing experience.
• New and revised indications for Xeloda are for cancers of the colon, rectum, breast, the gastrointestinal tract and the pancreas. The drug’s dosage regimen also has been revised and updated for several indications, including the option for a lower starting dose for patients with metastatic breast cancer. For more information on the new indications and dosage regimens, as well as possible side effects and other drug safety information, see Xeloda’s prescribing information.
• On Wednesday, the FDA announced that registration is now open for a virtual public meeting about the FDA’s role in the Association of American Feed Control Officials (AAFCO) animal feed ingredient definition process. The meeting is on February 9, 2023 and will specifically look at how to improve the FDA’s role in the AAFCO feed ingredient definition process and how the FDA could gather stakeholder input on the safety of each pending ingredient definition. The meeting will not address other aspects of animal food regulation. Stakeholders interested in presenting at the virtual public meeting must indicate their interest when completing the registration form. A docket has also been opened to collect public comments through March 9, 2023. 
• On Wednesday, the FDA responded to several objections and requests for a hearing on provisions in the yogurt standard of identity final rule, published on June 9, 2021.
• On Tuesday, the FDA warned the public about the dangers of fraudulent over-the-counter flu products and offered tips to spot these unproven products. Flu season may bring out dishonest sellers hawking fraudulent over-the-counter products that claim to prevent, treat, or cure the flu. These unproven products, sold online and in stores, haven’t been evaluated by the FDA for safety and effectiveness. In fact, they might be dangerous to you and your family.
• On Tuesday, the FDA posted a warning letter to Thriftmaster Texas, LLC for illegally selling products containing cannabidiol (CBD) for uses including treating or preventing COVID-19. People may confuse CBD-containing products for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, are especially concerning. Specific information about how FDA regulates cannabis-derived products can be found here. Consumers concerned about COVID-19 should consult with their health care provider.
• On Tuesday, the FDA approved Idacio (adalimumab-aacf), a biosimilar for Humira (adalimumab), marking the 40th biosimilar approval in the U.S. Idacio is a tumor necrosis factor blocker indicated for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis and Plaque Psoriasis. Idacio may cause an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and other infections. For more information on Idacio, including instructions for use and the risks and associated adverse reactions, read the prescribing information. The agency also launched the newly redesigned biosimilars webpage, providing updated information for patients and health care providers in a modernized, visually appealing format.
• On Tuesday, the FDA announced revised labeling and packaging for Micotil 300 (tilmicosin injection), an injectable drug for use in certain cattle and sheep. These changes address risks to people handling or administering the drug. Human injection with Micotil 300 can lead to severe cardiac effects and death.
• 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 1181 revisions to EUA authorizations
     

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