FDA publishes a guidance recommending that applicants change the labeling for antihypertensives to include standard language on the cardiovascular ben...
CDER Office of Prescription Drug Promotion researchers look for the most effective way to communicate risk information in character space limited comm...
FDA warns La Palma, CA-based Adarsh Daswani about issues in his work conducting a clinical investigation of an investigational drug.
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.
