FDA grants Alcyone Lifesciences a breakthrough device designation for its ThecaFlex DRx System, an implantable subcutaneous port and intrathecal cathe...
FDA Review posts the Federal Register notices for the week ending 2/8/2019.
Federal Register notice: FDA seeks comments on an information collection extension for Center for Devices and Radiological Health Appeals Processes.
Federal Register notice: FDA seeks comments on a new information collection for Proposed Suffix for the Proper Name of a Biological Product.
Federal Register notice: FDA makes available a draft guidance entitled Nonproprietary Naming of Biological Products: Update.
FDA seeks comments on a new information collection related to a proposed Healthcare Professional Survey of Professional Prescription Drug Promotion.
FDA issues a letter to health care providers to alert them to an increasing number of medical device reports associated with surgical staplers for int...
American Health Packaging recalls one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finis...