FDA issues a new drug marketing status notification guidance, an initial step in enhancements to the Orange Book.
FDA approves a Kurin 510(k) for its Kurin PIV18 peripheral IV configuration with an extension set, which is intended for use with infusions.
Tris Pharma recalls three lots of infants ibuprofen concentrated oral suspension, 50 mg per 1.25 mL, because the products have been found to potential...
FDA extends its review of a Nuvectra PMA for its Virtis Sacral Neuromodulation system, indicated for use in treating chronic urinary retention and sym...
FDA clears a XableCath 510(k) for its Peripheral Crossing Catheters, intended for use to cross challenging lesions in both arterial chronic total occl...
FDA approves Mylans application for the first generic form of GlaxoSmithKlines Advair Diskus asthma inhalation powder.
A year-long Bloomberg News investigation highlights concerns that FDA generic drug surveillance inspections have been dropping while the number of app...
FDA sends University of Miami Reproductive and Fertility Center a Warning Letter for significant deviations from the regulations for human cells, tiss...