The US Food and Drug Administration's (FDA) recent proposal to overhaul the manner in which generic drug manufacturers may update the safety warnings on their labels may be receiving warm praise from ...
Regulatory Focus' ongoing series of Regulatory Explainers take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we ...
Project Renewal updates older oncology drug labels to ensure clinical relevance and scientific accuracy, involving external experts and early-career scientists. Fludarabine phosphate's updated label ...
Sen. Rick Scott (R-Fla.) on Thursday unveiled legislation that would require prescription drug labels to include information about where medications originated from. Scott’s bill, shown first to The ...
NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx’s preservative-free ketamine ...
Participants examined the challenges and opportunities to update oncology drug labeling that is inconsistent with the current evidence base and use in clinical practice. Discussions focused on what ...
WASHINGTON — An experimental drug from a unit of Johnson & Johnson appears effective at treating a severe skin disease, though government regulators said Friday it also could slightly increase cancer ...
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