Federal Register notice: FDA updates the availability of guidance documents related to the Covid-19 public health emergency.
Federal Register notice: FDA determines that Hospiras sodium chloride 14.6% solution for injection (50 milliequivalent/20 milliliters) in plastic cont...
FDA grants a de novo marketing authorization for Neurolutions IpsiHand Upper Extremity Rehabilitation System for use in adult patients undergoing stro...
Cordis recalls (Class 1) its Precise PRO Rx Carotid System because of the potential for the distal tip to become separated from the lumen wire.
FDA says BD is recalling 30 lots of its ChloraPrep 26 mL applicator due to a defective applicator.
FDA grants accelerated approval to GlaxoSmithKlines Jemperli to treat some endometrial cancers in patients with a specific biomarker determined by an ...
FDA grants 510(k) clearance to the Orthofix Forza titanium spacer system.
A Texas state senator introduces legislation to facilitate manufacturer sharing of information on off-label uses for drugs.