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Federal Register notice: FDA seeks comments on an information collection extension entitled Generic Clearance for Quantitative Tes...[ Price : $8.95]
CDER explains how it used artificial intelligence/machine learning (AI/ML) to help identify the patient population most likely to ...[ Price : $8.95]
FDA grants Zymedi an orphan drug designation for ZMA001, a monoclonal antibody in development for pulmonary arterial hypertension.[ Price : $8.95]
FDA and Health Canada issue a notice alerting healthcare providers and facilities about the safe use of Megadyne Medical Products ...[ Price : $8.95]
Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in can...[ Price : $8.95]
Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic ...[ Price : $8.95]
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...[ Price : $8.95]
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.