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- FDA launches Rare Disease Framework to embed patient input early in drug developmentFDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
- FDA orders label warnings for GLP-1 drugs over rare eye-loss riskThe U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…