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FDA warns Medley, FL-based Evi Labs about CGMP violations in its work as a contract drug manufacturer.[ Price : $8.95]
FDA publishes a draft guidance entitled Transfer of a Premarket Notification (510(k)) Clearance Questions and Answers.[ Price : $8.95]
The Government Accountability Office says there are things HHS, FDA, and other units should do to help create a coordinated nation...[ Price : $8.95]
Two former FDA officials add their names to a class-action wrongful termination lawsuit alleging the federal government knowingly ...[ Price : $8.95]
Anonymous and named sources raise questions for NBC News about FDAs use of internal AI tools in product reviews and approvals.[ Price : $8.95]
FDA warns Koreas DFI Co., Ltd. about Quality System and Medical Device Reporting violations in its manufacturing of reagent strips...[ Price : $8.95]
Three Morgan Lewis attorneys tell regulated product sponsors to watch for AI involvement in FDA reviews and be prepared to respond...[ Price : $8.95]
FDA accepts for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for certain adult patients with rela...