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An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosami...[ Price : $8.95]
FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to cr...[ Price : $8.95]
FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for ad...[ Price : $8.95]
FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.[ Price : $8.95]
FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...[ Price : $8.95]
Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.[ Price : $8.95]
An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...[ Price : $8.95]
A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS se...