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- FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelinesThe U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
- Rare disease drugmakers brace for potential Trump administration price cuts amid GOP push on health‑care fraudRare disease drugmakers are watching the Trump administration closely as proposals emerge that could force lower prices for their specialty therapies. The companies are exploring strategies to miti…