FDA Roundup: December 30, 2022
SILVER SPRING, Md., Dec. 30, 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 announced, through a Constituent Update and corresponding rule in the Federal Register, that January 1, 2026, will be the uniform compliance date for final food regulations that are issued in calendar years 2023 and 2024. The FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact on the food industry of having to respond separately to each labeling change.
- On Wednesday, the FDA approved Briumvi (ublituximab-xiiy) injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Researchers demonstrated Briumvi’s efficacy in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate (ARR) over the treatment period. In both studies, Briumvi significantly lowered the ARR compared to teriflunomide. The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.
- On Wednesday, the FDA issued the 2022 edition of the FDA Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety. The 2022 Food Code specifically addresses food donations for the first time and this new information is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy, which was rolled out in September at the White House Conference on Hunger, Nutrition, and Health, provides a roadmap of actions the federal government is taking to end hunger and reduce diet-related diseases by 2030 – all while reducing disparities.
- On Wednesday, the FDA published an interview with the agency’s “top cop,” FDA Assistant Commissioner for Criminal Investigations Catherine Hermsen, who is retiring this week. In the interview, Hermsen reflects on the international aspects of her over 30 years of federal law enforcement, including the dual challenges posed by increased globalization and the rise of e-commerce.
- On December 23, the FDA approved a supplemental application for Plan B One-Step. The FDA’s approval of this application removes some of the information on mechanism of action from the Drug Facts label and updates the mechanism of action information in the Consumer Information Leaflet for Plan B One-Step to reflect the best available science.
- COVID-19 testing updates:
- As of today, 443 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 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, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
- The FDA has authorized 43 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1196 revisions to EUA authorizations.
Media Contact: FDA Office of Media Affairs, 301-796-4540
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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.
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SOURCE U.S. Food and Drug Administration