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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...[ Price : $8.95]
Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspecti...[ Price : $8.95]
FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.[ Price : $8.95]
FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug revi...[ Price : $8.95]
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 20262...[ Price : $8.95]
Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...[ Price : $8.95]
FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...[ Price : $8.95]
FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.