FDA publishes cases studies to help patients, health professionals, and others to learn more about the role of biomarkers and biomarker qualification ...
The Government Accountability Office says that consumer groups are unclear on the roles FDA and FTC play in oversight over memory and other dietary su...
FDA issues an updated question-and-answer guidance to facilitate implanting the 2005 ICH E14 guidance.
Millennium asks FDA to apply restrictions to a Fresenius 505(b)(2) application for a bortezomib product.
Federal Register notice: FDA seeks notice from industry organizations interested in participating in the selection of a nonvoting industry representat...
Federal Register notice: FDA seeks comments on proposed research entitled Disclosures in Professional and Consumer Prescription Drug Promotion.
CDRHers Jeffrey Shuren and Bram Zuckerman praise Center efforts to speed innovation in heart valve devices.
FDA says Phillips is recalling to the retail level all lots of nine topical products produced in the last three years.