FDA Review posts the Federal Register notices for the week ending 4/12/2019.
FDA Review posts product approval summaries for the week ending 4/12/2019.
Federal Register notice: FDA determines the regulatory review period for Shionogis Symproic (naldemedine tosylate) for treating opioid-induced constip...
Federal Register notice: Based on a de novo request, FDA classifies Timpels Enlight 1810 ventilatory electrical impedance tomograph into Class 2.
FDA approves an expanded label for Mercks Keytruda, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of certain patients with Sta...
Federal Register notice: FDA classifies suitable medical device accessories into Class I as required by the FDA Reauthorization Act of 2017.
Former Pharmakon Pharmaceuticals CEO Paul J. Elmer and compliance director Caprice R. Bearden are convicted of conspiracy to defraud FDA and nine coun...
A new FDA update says the findings from duodenoscope studies now show that up to 5.4% of all properly collected samples tested positive for high conce...