An Epstein Becker & Green client alert predicts an imminent confirmation of Scott Gottlieb to be the next FDA commissioner, which should be a win for ...
FDA clears an Advanced Cooling Therapy 510(k) for use of its Esophageal Cooling Device with the Altrix Precision Temperature Management System by Stry...
Two attorneys say a recent Pennsylvania federal court decision shows courts are narrowing the situations in which they impose liability under the Fals...
FDA clears an Additive Orthopedics 510(k) for its 3D printed Locking Lattice Plating System and its use to address stabilization and fusion of fractur...
FDA clears an Entellus Medical 510(k) for the XprESS ENT Dilation System and its use in patients with persistent Eustachian tube dysfunction.
CDER Office of Hematology and Cancer Products staff list possible reasons why only one drug has been approved since 2006 for use with radiation in cur...
Attorney Kate Stewart says the FBI is warning about the cybersecurity risk in FTP servers in healthcare facilities operated in an anonymous configurat...
Federal Register notice: FDA extends the comment period for the draft guidance for industry #187 Regulation of Intentionally Altered Genomic DNA in An...