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…
Spectrum Brands Pet LLC Recalls a Single Lot of Tetra Reptomin Reptile Food for Aquatic Turtles Because of Possible Salmonella Health Risk
Spectrum Brands Pet LLC (“SPG”) is voluntarily recalling its Tetra ReptoMin 3-In-1 SELECT-A-FOOD reptile food product intended for aquatic turtles…
JFE Franchising, Inc. Recalls A Limited Number of Cucumber Products Because Of Possible Health Risk
Houston, TX (May 23, 2025) – JFE Franchising, Inc. of Houston, TX, is recalling a limited number of fresh-cut cucumber…
Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
Big Y Foods Recalls Made-To-Order Subs, Wraps and Paninis Sold in Massachusetts and Connecticut Because of Possible Health Risk
Big Y Foods of Springfield, MA is voluntarily recalling some Made-To-Order Subs, Wraps and Paninis sold between 5/20 and 5/21…
Albertsons Companies Voluntarily Recalls Three Store-Made Deli Items Containing Recalled Cucumber Supplied by Fresh Creative Foods Due to Possible Salmonella Contamination
Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Albertsons Companies has voluntarily recalled…