FDA approves a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase-positive non-small cell...
FDA warns California dentist William Domb about violations in his conduct of a clinical study using ozone generators.
A Federal Trade Commission report says that the number of potential pay-for-delay patent dispute settlements in FY 2015 was significantly lower than i...
FDA warns Chinas Guangdong Zhanjiang Jimin Pharmaceutical Co. about CGMP and other violations in its production of finished pharmaceuticals for OTC us...
Sixth Circuit Appeals Court decision upholds dismissal of a False Claims Act whistleblower case against Bristol-Myers Squibb based on alleged off-labe...
Federal Register notice: FDA classifies genetic health risk assessment systems into Class 2 (special controls).
FDA posts a guidance on Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention that discusses the overall development program and cl...
Federal Register proposed order: FDA proposes to reclassify the needle destruction device, renaming the device to sharps needle destruction device, fr...