FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.
FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.
Eugene, OR — May 5, 2026, Market of Choice (MOC) is recalling MOC Vegan Kale Caesar Salad (9.5 oz) due to the presence of an undeclared sesame allergen. People who have an allergy or severe sensitivity to sesame run the risk of serious...
FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
Ocinet, Inc., of Downey, California, is recalling all “…And Kimchi” branded sliced kimchi, UPC 8541200408, UPC 8541200409, and UPC 8541200411 (the “Product”) because the Product contains undeclared fish (anchovies). People who have an...
HANOVER, PA -- (BUSINESS WIRE) – Utz Quality Foods, LLC, a subsidiary of Utz Brands, Inc., is issuing a voluntary recall in the United States of certain limited varieties of Zapp’s® and Dirty® potato chips. This voluntary recall follows...
Boulder, CO – May 2, 2026 – The a2 Milk Company (“a2MC”) has voluntarily recalled three specific batches of its imported a2 Platinum Premium USA label infant formula 0-12 months (“Product”) due to the presence of cereulide. The Product...
FT. LAUDERDALE, FL – May 1, 2026 – Trividia Health, Inc., a global leader in diabetes management, today provided an important update to the medical device labeling correction it announced on February 6, 2026, for all TRUE METRIX®, TRUE...
FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.
Rotarix approval page indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.
Second Nature Brands of Madison Heights, MI, is voluntarily recalling certain 10-ounce packages of SECOND NATURE KETO CRUNCH SMART MIXTM because the product may contain undeclared cashews, pistachios, and cherries. Individuals who have...
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts...
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...
The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease...
On March 12, 2026, the Committee will meet in open session to discuss and make recommendations on the strain composition of influenza virus vaccines for use in United States during the 2026-2027 influenza season.
FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
Pork King Good has voluntarily recalled specific Sour Cream & Onion pork rind and seasoning products. This recall was initiated following a recall by California Dairies, Inc. concerning potential Salmonella contamination in milk...
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is hosting its next virtual town hall on June 4, 2026. During this town hall, experts from OTP’s Office of Review Management &...
The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
FDA announces results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market.
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT).
For Immediate Release - BETHLEHEM, PA – APRIL 28, 2026 – B. Braun Medical Inc. is voluntarily recalling two lots of Lactated Ringer’s Injection, E7500, 1L, to the hospital/healthcare facility level. The product has been found to have...
Ghirardelli Chocolate Company of San Leandro, California is voluntarily recalling certain powdered beverage mixes because they have the potential to be contaminated with Salmonella. This action follows a California Dairies, Inc. milk...
We R Nuts of Port Washington, New York is recalling 254 Uncle Giuseppe’s branded 11oz containers of milk chocolate bridge mix, because it may contain undeclared Milk, Soy and Cashews. People who have an allergy or severe sensitivity to...
On April 18, President Trump issued an Executive Order directing the U.S. Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and...
Ferris Coffee & Nut Co., Grand Rapids, Michigan is recalling a single lot of Frederik’s by Meijer Vanilla Bourbon Trail Mix 9 oz. because it may contain undeclared wheat and soy. People who have an allergy or severe sensitivity to...
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.
ASHEVILLE, NC – April 23, 2026 – French Broad Chocolates PBC is recalling Bette’s Bake Sale Bonbon Collection in 6pc, 12pc, and 24pc boxes with batch numbers 260414 and 260417 due to the potential to contain undeclared walnuts. People...
CMS and FDA announce the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a new pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 3/27/2026 Short Title (70 char) Revive Rx LLC dba Revive Rx Pharmacy. Houston, TX. 483 issued 3/27/2026 FEI Number 3016710945 Firm Name Revive Rx...