Federal Register notice: FDA extends the comment period on a draft guidance entitled Modifications to Compliance Policy for Certain Deemed Tobacco Pro...
Myriad Genetics files the first module of a planned PMA for the myChoice HRD CDx test, a companion diagnostic for identifying certain patients with ov...
Three DIA Piper attorneys describe four key issues facing FDA acting commissioner Norman Sharpless.
Two drug companies offer suggestions for an FDA draft guidance on developing drugs to treat eosinophilic esophagitis.
FDA approves Amgen/UBS Evenity to treat osteoporosis in postmenopausal women at high risk of fracture.
FDA says it is ordering changes to labeling for opioids used in outpatient settings to help providers and patients safety decrease the dose or wean of...
FDA and FTC warns Relieveus that it is marketing CBD markets online that are unapproved and misbranded new drugs and are subject to FTC advertising re...
FDA releases its latest batch of Warning Letters that include Apollo Care and Cord for Life.