Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

This page provides details on the Notification Process for Transfusion Related Fatalities and Donation Related Deaths.

Information about tissues, questions and answers, donor screening and testing, donor eligibility

Fresh Creative Foods is voluntarily recalling a single item with a specific use by date, produced at a regional facility and distributed to limited Trader Joe’s locations. The product is Trader Joe’s Hot Honey…

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.

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an…

List of new drug applications

FDA is responsible for ensuring the safety of the Nation’s blood supply. While a blood supply with zero risk of transmitting infectious disease may not be possible, there are several measures taken by FDA…

Cromer Food Services, Inc. is recalling all lots of our CFS Cromer Food Service brand Chicken Salad on White Sandwich with UPC 31166 & UPC 13172 because it contains undeclared milk.

This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.