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FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the ag...[ Price : $8.95]
Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under ...[ Price : $8.95]
Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked me...[ Price : $8.95]
CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevatio...[ Price : $8.95]
The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.[ Price : $8.95]
A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is...[ Price : $8.95]
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.[ Price : $8.95]
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.