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- FDA outlines inspection overhaul, proposes IND reforms, and greenlights a disputed cancer therapyFDA officials announced a plan to restructure the agency’s inspectional operations, aiming to make inspections more efficient and focused. The proposed changes include consolidating regional office…
- Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US statesRoche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…