People who have allergies to milk/wheat/soy run the risk of serious or life-threatening allergic reaction if they consume these products. The three recalled “Monkey Spit BBQ Sauces" were distributed locally in retail stores on the...
CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.
Description of CBER's Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.
Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review.
This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee (VRBPAC) December 12, 2024 meeting announcement and materials.
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 10/28/2024 Short Title (70 char) QuVa Pharma, Inc. Sugar Land, TX. 483 issued 10/28/2024 FEI Number 3012053582 Firm Name QuVa Pharma Inc Record Type...
Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.
Thimerosal is a compound that has been widely used as a preservative in a number of biological and drug products. All vaccines routinely recommended for children 6 years of age and younger in the U.S. are available in formulations that...
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
New York Mutual Trading Co., Inc of Secaucus, NJ is recalling 7.05 oz of Prepared Monkfish Liver (Ankimobo) because the package label contains undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen...
This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including source...
CBER regulates vaccine products. Vaccine information includes a listing of vaccines approved for marketing, questions about vaccines, vaccine safety and availability, and vaccine-related guidance documents, notices, and rules.
FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products.
January 14, 2025 – The Quaker Oats Company today issued a recall of a limited number of two pound boxes of Pearl Milling Company Original Pancake & Waffle Mix that may contain undeclared milk, after being alerted by a retail partner....
FDA announces a proposed rule requiring food manufacturers to display a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label, referred to as the Nutrition Info box, would display nutrition...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 11/12/2024 Short Title (70 char) Taylor Farms Colorado, Inc. Colorado Springs, CO. 483 issued 11/12/2024 FEI Number 1783599 Firm Name Taylor Farms...
Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.
Lifestyle Evolution Inc., is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of...
The Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white. People who have an allergy or severe sensitivity to eggs, run the risk of...
The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the...
The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality.
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.
The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen carried in the blood – across the range of skin...
STATESVILLE, NC - January 3, 2025- Blue Ridge Beef is recalling 1,350 lbs. of their 2 1b log Kitten Mix Lot N25-0716 UPC 8542980013436 due to a contamination of Salmonella. (Lot numbers are stamped in the clips on the end of the...
Dierbergs is recalling all 16oz Premium Home-Style Mashed Potatoes with a Sell By Date of January 09, 2025. The product carries an undeclared allergen of Wheat. The affected product is identifiable by a label ID number of 92 in the lower...
Abbey Specialty Foods of Fairfield, NJ is recalling Wicklow Gold Cheddar Nettle & Chive 5.2 oz product and Wicklow Gold Cheddar Tomato & Herb 5.2 oz product because they have the potential to be contaminated with Listeria...
Soledad, Calif. – Dec. 27, 2024 – Braga Fresh is voluntarily issuing a precautionary advisory of a single production lot of washed and ready-to-eat 12oz Marketside Broccoli Florets with best if used by date.