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FDA cites Neeyaan LLC for multiple GMP deficiencies, including the firms failure to validate drug manufacturing processes, conduct...[ Price : $8.95]
Mosaic Clinical Technologies petitions FDA to explain the regulatory principles it is applying to artificial intelligence vision l...[ Price : $8.95]
FDA asks for stakeholder responses to six discussion questions in a paper on regulating generative AI-enabled medical devices.[ Price : $8.95]
FDA warns Chinas Tianjin Kilo Pharmaceutical Sci-tech Co. about CGMP deviations the agency found in records it requested on the co...[ Price : $8.95]
McGuireWoods partner Clint Narver announces his departure from the law practice to rejoin FDA as director of the Office of Compoun...[ Price : $8.95]
Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide.[ Price : $8.95]
Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and m...[ Price : $8.95]
FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted throu...