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Federal Register notice: FDA makes available a draft guidance entitled Elemental Impurities in Animal Drug Products Questions and Answers.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...
Medical device manufacturer Alere agrees to pay $33.2 million to resolve a whistleblower suit alleging that it knowingly sold diagnostic devices that ...