In a move to avoid layoff notices sent to FDA staff working under the agencys user fee programs, Senate and House health committee leaders release a b...
Standard Homeopathic recalls all lots of Hylands Baby Teething Tablets and Hylands Baby Nighttime Teething Tablets sold in retail stores.
Eli Lilly and Incyte disagree with an FDA complete response letter requesting additional data for their NDA for baricitinib, a once-daily oral medicat...
FDA clears an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals ...
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...