FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational pharmacoepidemiologic...
CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the Division of Ophthalmi...
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FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.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...
