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FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsiderati...[ Price : $8.95]
FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs...[ Price : $8.95]
Novocure wins PMA approval for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients w...[ Price : $8.95]
The DC federal court rules in favor of FDA and MSN Pharmaceuticals as defendants in a suit filed by Novartis over the agencys appr...[ 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...