FDA warns Thibiant International about CGMP violations in its production of finished pharmaceuticals.
Janssen Pharmaceutical files a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethaso...
Federal Register notice: FDA seeks comments on an information collection extension for Clinical Laboratory Improvement Amendments (CLIA) of 1988 waive...
Federal Register notice: FDA makes available a final guidance entitled Standards Development and the Use of Standards in Regulatory Submissions Review...
CDER regulatory advisor Joshua Silverstein uses a Webinar to describe provisions in the final guidance on the least burdensome approach to regulatory ...
FDA commissioner Scott Gottlieb and CBER director Peter Marks describe agency steps to develop a technology to reduce blood pathogens.
Public Citizens Sidney Wolfe tells the FDA General and Plastic Surgery Devices Panel that FDA should require extensive pre-approval testing of permane...
FDA clears an InControl Medical 510(k) for the Attain, an over-the-counter non-implantable muscle stimulator designed for at-home use to help treat wo...