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Four drug companies recommend changes to an FDA draft guidance on developing drugs to treat major depressive disorder.[ Price : $8.95]
Sen. Edward Markey says FDA may have ignored REMS signals of inappropriate prescribing of a specific class of fentanyl products.[ Price : $8.95]
FDA warns Japans Kyowa Hakko Bio Co. about repeat CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Quality Attribute Considerations for Chewable Tablets.[ Price : $8.95]
FDA extends expiration dates on some EpiPen lots to help ease product shortage.[ Price : $8.95]
JAMA deputy editor Gregory Curfman calls for congressional action to resolve the question of who a consumer can sue when injured b...[ Price : $8.95]
FDA clears a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pyl...