A Florida U.S. attorney has subpoenaed information from Endo relating to its oxymorphone products.
FDA commissioner Scott Gottlieb releases a 2018 strategic policy roadmap with four priorities.
FDA reminds healthcare providers about possible pneumothorax events associated with feeding tube placement procedures using enteral access systems.
The BMJ questions whether vaccine researchers misled regulators and trial participants about the safety of a new tuberculosis vaccine based on animal ...
FDA issues Becton Dickinson a Warning Letter as part of its investigation of Vacutainer blood collection tubes used in Magellan Diagnostics LeadCare a...
Edwards LifeSciences recalls its Certitude Delivery System due to a molding overflow defect in the button valve within the loader.
David M. Link, the founding director of FDAs Bureau of Medical Devices (1974-80), precursor organization of CDRH, dies at the age of 87.
Federal Register notice: FDA determines that the regulatory review period for RaQualia Pharmas Entyce (capromorelin), indicated for appetite stimulati...