Newsletter - November 7, 2019
FDA Review Needed to Address Bias in Health Algorithms
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. Read More
Reorganization of FDA’s Oncology Products Reviewers Affects IND and NDAs
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...Read More
FDA Review Needed to Address Bias in Health Algorithms
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. Read More
Reorganization of FDA’s Oncology Products Reviewers Affects IND and NDAs
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...Read More
