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Three House members raise concerns about FDA oversight of a Bayer post-marketing study of its Essure birth control device that app...[ Price : $8.95]
FDA publishes an International Council For Harmonization guidance entitled E9 (R1) Statistical Principles for Clinical Trials: Add...[ Price : $8.95]
Federal Register notice: FDA publishes six medical device classification notices.[ Price : $8.95]
Federal Register notice: FDA reopens the comment period to allow additional time for comments related to a workshop on Voluntary M...[ Price : $8.95]
FDA says its lab findings again link Rugby Dioctos oral liquid docusate sodium to Burkholderia cepacia.[ Price : $8.95]
Federal Register notice: FDA determines that EKR Therapeutics hypertension drug Cardene SR (nicardipine HCl) extended-release caps...[ Price : $8.95]
FDA clears three antimicrobial susceptibility tests for determining the appropriate usage of Melinta Therapeutics Baxdela (delaflo...[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the cont...