FDA warns Ichibancho, Japan-based Neitz Instruments Company about Medical Device Reporting violations in its manufacturing of its halogen ophthalmosco...
FDA warns Dr. Jeffrey Taub and the Childrens Hospital of Michigan about objectionable conditions in two clinical investigations.
A California appeals court affirms in part and reverses in part a trial court decision in a case involving negligence claims against Gilead over its H...
FDA publishes a draft guidance on requesting reconsideration of ANDA decisions to reflect the current GDUFA reauthorization.
In a project conducted with FDA, the Clinical Trials Transformation Institute identifies barriers to timely and complete reporting of clinical trials ...
FDA revises its guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as...
Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512...
Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare pediatric disease pr...
