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Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical tria...[ Price : $8.95]
CDER director Patrizia Cavazzoni says the Center worked with CBER to launch in 2023 the START program, providing selected particip...[ Price : $8.95]
FDA posts a consumer-focused explanation of how CDER determines and manages drug shortages.[ Price : $8.95]
CDRH pilots medical device trial participation snapshots to provide key information about clinical trials that supported their app...[ Price : $8.95]
FDA makes recommendations to prevent damage to wearable medical devices from X-ray imaging, including CT scans.[ Price : $8.95]
FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.[ Price : $8.95]
Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not wit...[ Price : $8.95]
Federal Register notice: FDA issues IntraBio a priority review voucher after determining its recent approval of Aqneursa (levacety...