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U.S. Food and Drug Administration (FDA)

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The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act. Source

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Country United States of America
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Ukrop’s Homestyle Foods Announces a Voluntary Recall Due to Possible Foreign Object

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By Product NameUpcnet WTShelf-
| U.S. Food and Drug Administration (FDA)
More Recalls, Market Withdrawals, & Safety Alerts Summary Company Announcement Date: July 30, 2026 FDA Publish Date: August 01, 2026 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Baked products have potential for presence of aluminum slivers from the pans that were used Company Name: Ukrops Homestyle Foods Brand Name: Brand Name(s) Product Description: Product Description Baked Spaghetti and Bread Pudding products Company Announcement Ukrop's Homestyle...
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Alphanate Lead Page

| U.S. Food and Drug Administration (FDA)
STN: BL 102475 Proper Name: Antihemophilic Factor/von Willebrand Factor Complex (Human) Tradename: Alphanate Manufacturer: Grifols Biologicals Inc Indication: Treatment and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A.
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Lidl US Expands Recall of Eridanous Shortbread Cookies Due to Undeclared Wheat, Soy, Milk, Egg and Tree Nut (Coconut) Allergens

| U.S. Food and Drug Administration (FDA)
More Recalls, Market Withdrawals, & Safety Alerts Summary Company Announcement Date: July 31, 2026 FDA Publish Date: July 31, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Additional product with undeclared wheat, soy, milk, and egg allergens due to foreign language packaging that did not contain English ingredients, nutrition facts, or allergen declarations.
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FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

| U.S. Food and Drug Administration (FDA)
On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).
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Event Title Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products September 10, 2026

| U.S. Food and Drug Administration (FDA)
Date: September 10, 2026 Time: 8:30 a.m. - 12:40 p.m. ET This virtual event is FREE! Register Event Details This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products. FDA uses Generic Drug User Fee Amendments (GDUFA)-funded regulatory science and research to develop and revise general and product-specific guidances and to support abbreviated new drug application (ANDA) review.
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Ventilator Correction: Resmed Issues Correction for Astral Ventilator

| U.S. Food and Drug Administration (FDA)
This is an update to an Early Alert. The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Figure 1. Astral 150.
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Drug Registration and Listing Instructions

| U.S. Food and Drug Administration (FDA)
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates to maintain an accurate and current status: Establishment registration Labeler code Drug product listing(s) FDA has adopted extensible markup language (XML) files in the structured product labeling (SPL) format for users to submit registration and listing data.
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Developing and Manufacturing Drugs Including Biologics

| U.S. Food and Drug Administration (FDA)
FDA evaluates prescription drugs, including biologics, and some over-the-counter drugs, before they can be distributed in the United States to help ensure those products are safe and effective. Manufacturers and product sponsors that produce drugs, including active pharmaceutical ingredients (API), and biologics are subject to certain laws and regulations that ensure these products are manufactured in compliance with appropriate quality standards.
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Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry July 2026

| U.S. Food and Drug Administration (FDA)
Home Regulatory Information Search for FDA Guidance Documents Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Search for FDA Guidance Documents Docket Number: FDA-2016-D-1254 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.” This guidance provides...
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Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts July 2026

| U.S. Food and Drug Administration (FDA)
Home Regulatory Information Search for FDA Guidance Documents Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts Search for FDA Guidance Documents Docket Number: FDA-2026-D-4272 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance is intended to help applicants develop container closure systems and device constituent parts for...
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U.S. Food and Drug Administration (FDA) Journalists

Bernstein, Jessica