Federal Register notice: FDA sends to OMB an information collection revision entitled Electronic Records; Electronic Signatures 21 CFR Part 11.
FDA warns South Koreas Woorilife & Health about CGMP violations in its manufacturing of over-the-counter drugs.
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FDA publishes a draft guidance on requesting reconsideration of ANDA decisions to reflect the current GDUFA reauthorization.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...
