FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approval for some rectal c...
Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting program created under MDU...
CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attributes.
FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended to help users in acqu...
Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they did not have FDA autho...
FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energy and Commerce joint...
FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.
An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals char...
