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Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes...[ Price : $8.95]
FDA publishes a guidance on optimizing dosage for oncologic drug and biologic therapies.[ Price : $8.95]
FDA approves an Amneal Pharmaceuticals NDA for Crexont (carbidopa and levodopa) extended-release capsules for treating Parkinsons ...[ Price : $8.95]
Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn fro...[ Price : $8.95]
Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit...[ Price : $8.95]
FDA gives accelerated approval to Novartis Fabhalta for reducing proteinuria in primary IgA nephropathy.[ Price : $8.95]
FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.[ Price : $8.95]
FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.