Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical ...
Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release tablet was not withdr...
FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer
Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal court to grant summary judgment in their favor in ...
The Justice Department says Liveyon founder and CEO John Kosolcharoen has been sentenced to 36 months in prison after pleading guilty to one count of ...
Fresenius Kabi recalls (Class 1 device correction) its Ivenix Infusion System Large Volume Pump software due to multiple software and cybersecurity vu...
Federal Register notice: FDA announces an 11/21 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review an AstraZeneca supplemental ...
Federal Register notice: FDA announces that a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting will review a Lexicon Pharmaceutical...
