Fresenius Kabi recalls a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vial due to a trace am...
Federal Register notice: FDA posts 30 additional draft and revised draft product-specific guidances on the design of bioequivalence studies to support...
Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a person that has an ap...
An 11/20 CDER Webinar will explain changes to the Office of Prescription Drug Promotion core launch review process.
FDA posts online information for vaccine manufacturers to submit safety reports electronically to CBER.
FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction p...
FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.
FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and co...