Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean…
Face Rock Creamery Voluntarily Recalls Vampire Slayer Garlic Cheddar Curds Because of Possible Health Risk
Face Rock Creamery of Bandon, Oregon is voluntarily recalling two specific lots of its Vampire Slayer Garlic Cheddar Curds, 6oz.…
International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils, because it may…
Lipari Foods Issues Allergy Alert on Undeclared Milk in “Dark Chocolate Nonpareils”
Lipari Foods of Warren, MI, is recalling its 14-ounce packages of JLM Branded “Dark Chocolate Nonpareils” food treats because they…
Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate Nonpareils
Weaver Nut Company, Inc. is recalling the following chocolate products with specific lot codes, due to potential undeclared milk allergens.…
Submit a Standardized Data Sample to FDA
FDA would like to assist sponsors and applicants who have not previously submitted an eCTD and/or standardized study data, and…
Submit an eCTD v4.0 or Standardized Data Sample to the FDA
Learn more about FDA’s process to validate sample new eCTD v4.0 submissions and standardized study datasets.
Electronic Regulatory Submission and Review
This page provides information about the electronic submission of regulatory information to the Center and the review of it by…
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with…
Santa Monica Seafood Voluntarily Recalls Atlantic Salmon Portions with Seafood Stuffing Due to Undeclared Soy
May 24, 2025, Santa Monica Seafood of Rancho Dominguez, CA, is voluntarily recalling Atlantic Salmon Portions with Seafood Stuffing because…