FDA warns DuPont Nutrition USA about CGMP deviations in its manufacturing of the widely-used drug excipient Avicel.
FDA describes two new issues that have occurred in some reworked Philips Respironics Trilogy 100 and 200 ventilators.
Retired FDA top cop Catherine Hermsen says there is a need to expand collaboration with regulators in other countries to combat international criminal...
Reactions to a Congressional report on FDAs 2021 controversial review and approval of Biogens Alzheimers drug Aduhelm sharply criticize the approval a...
FDA publishes an International Council for Harmonization guideline on a clinical electronic structured protocol.
President Biden signs into law FDAs fiscal year 2023 spending bill as part of the end-year omnibus legislation (HR 2617, Consolidated Appropriations A...
FDA grants Ardelyx appeal of a complete response letter for its Xphozah to treat adult patients with chronic kidney disease on dialysis with hyperphos...
FDA Webview posts the Federal Register notices that published during our annual holiday break.
