FDA officials examine real world evidence and its potential to contribute efficiently to current knowledge gained from traditional clinical trials.
Federal Register Notice: FDA makes available a guidance on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notifi...
Feds arrest several former pharmaceutical executives and managers at Insys Therapeutics on charges that they led a nationwide conspiracy to bribe medi...
ProNova Solutions receives FDA 510(k) clearance for its SC360 proton therapy system, a compact 360-degree pencil beam scanning proton therapy system c...
Federal Register Notice: FDA creates a docket to obtain comments on the final assessment of the Program for Enhanced Review Transparency and Communica...
FDA denies a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, asking that it publish a guidance for all naloxone produc...
FDA accepts for priority review an AstraZeneca BLA for durvalumab, a PD-L1 human monoclonal antibody for treating patients with locally advanced or me...
FDA expands approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions.