[ Price : $8.95]
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.[ Price : $8.95]
FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...[ Price : $8.95]
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...[ Price : $8.95]
Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace ...[ Price : $8.95]
Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit th...[ Price : $8.95]
FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition o...[ Price : $8.95]
FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency...