Day: November 7, 2019

In its ongoing reorganization efforts to align the review and oversight activities with the changing landscape of the products it regulates, FDA announced a major reorganization of its oncology product review divisions by renaming the main office to Office of Oncologic Diseases (ODD) and creating 6 new divisions within the office each focused on fewer … Read more

Health algorithms used to manage health decisions could lead to erroneous outcomes if data used to build and or train them is biased. This is particularly a concern since most health algorithms do not require a formal FDA approval particularly if they are labelled as MDDS products. A recent report demonstrated how a widely used … Read more