FDA approves an Abbott labeling change on its HeartMate 3 heart pump to eliminate aspirin as part of routine patient management.
A New York Times investigative article examines potential conflicts of interest with retiring CDRH director Jeff Shuren and his lawyer wife who repres...
FDA publishes a draft guidance with its current thinking on its policy for medical device predetermined change control plans.
PhRMA calls on FDA to make changes to a draft guidance on demonstrating biologic interchangeability with a reference product.
An FDA inspection at a third-party manufacturer cites inspection issues that have resulted in a complete response letter on a Regneron BLA for a multi...
FDA publishes the International Council for Harmonization E11A guidance intended to recommend and harmonize pediatric extrapolation in developing new ...
FDA clears the Nanox HealthCCSng V2.0 artificial intelligence coronary solution to help detect coronary artery calcium.
An FDA report on bioresearch monitoring FY 2023 metrics documents nearly 1,100 inspections through FDAs five Centers.
