FDA News Release
FDA Roundup: January 14, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the Interagency Food Safety Analytics Collaboration — a collaboration between the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the Food Safety and Inspection Service — has published its priorities for calendar years 2022–2023.
- Today, the FDA and the National Egg Regulatory Officials announced a new program for state egg and egg product regulators entitled the Egg Regulatory Program Standards. The standards are designed to integrate the regulatory activities of partner agencies into an efficient and effective process for improving egg and egg product safety in the U.S.
- The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New Drug Therapy Approvals 2021. As in the past, the drugs approved in 2021 span many areas of medicine and disease. This annual report, now in its 11th iteration, illustrates our role in helping bring innovative drug therapies that are safe and effective to patients in need. The FDA also published an FDA Voices on this report: Many Important Drugs Approved in 2021 as COVID-19 Pandemic Continues.
- On Jan. 13, the FDA made available the Interagency Working Group on Asbestos in Consumer Products (IWGACP) white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics). The white paper outlines scientific opinions on the testing of talc-containing cosmetic products to ensure reliable detection and identification of asbestos particles if present.
- On Jan. 13, the FDA 2021 Year in Review: Working for You report was released. This report offers just a small sampling of highlights of the agency’s work in 2021. The agency’s work in each of these areas (as well the countless efforts not mentioned) will have a profound impact on the health and safety of the American public for years to come.
- On Jan. 13, the FDA announced its approval of the new animal drug, Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and the first monoclonal antibody new animal drug approved by the FDA for use in any animal species. Solensia is available only by prescription from a licensed veterinarian because professional expertise is required to properly diagnose pain associated with osteoarthritis in cats, administer the injection and monitor the safe use of the product, including treatment of any adverse reactions.
- On. Jan. 12, the FDA announced it will hold a public hearing on Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox, a carcinogenic new animal drug used in swine feed. The public hearing will be held virtually on March 10, 2022, via Zoom. The FDA is also accepting public comments, data and information about the topics listed in the Federal Register Notice.
- On Jan. 12, the FDA issued a warning to patients and prescribers about the potential for dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder (OUD) and pain. The FDA cannot determine how likely it is that a patient will experience dental problems when taking buprenorphine medicines that dissolve in the mouth; however, the benefits of buprenorphine medicines for OUD and pain clearly outweigh the risks and are important tools in treating these conditions. Patients should notify their health care providers immediately and seek dental care should they experience any problems with their teeth or gums while taking buprenorphine medicines that are dissolved in the mouth.
- On Jan. 12, the FDA revoked the standard of identity for French dressing in response to a citizen petition from the Association for Dressings and Sauces. The petitioners shared information documenting that the standard is outdated. In December 2020, the agency issued a proposed rule and is now finalizing the rule based in part on its conclusion that revoking the standard will allow for greater innovation and more flexibility of products on the market.
- COVID-19 testing updates:
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 43 antigen tests. There are 69 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, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 763 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs