FDA warns Clover Custom Blending about CGMP and misbranding violations in its production of finished pharmaceuticals.
FDA warns Indias Keshava Organics about CGMP deviations in the production of active pharmaceutical ingredients.
FDA clears a Canon Medical Systems USA 510(k) for a suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflamma...
Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee.
A recent inspection of a Cipla drug manufacturing plant in Goa, India cites significant GMP violations.
Federal Register notice: FDA makes available a draft guidance entitled Elemental Impurities in Animal Drug Products Questions and Answers.
Federal Register notice: FDA amends a public workshop entitled Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices to ref...
A Delaware federal judge says FTC may re-file a narrowed complaint against Shire to determine whether the companys many Vancomycin petitions to FDA we...