FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical products.
FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.
Federal Register notice: FDA grants an Emergency Use Authorization to the U.S. Centers for Disease Control and Prevention for its in vitro diagnostic ...
FDA grants Laboratory Corp. of America an Emergency Use Authorization for the Labcorp Monkeypox PCR Test Home Collection Kit.
Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical Devices 21 CFR Par...
Philips North America recalls its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue where the coil heats up...
Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingredients in NDAs and A...
Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that produced inaccuratel...
