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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…
- EMA releases updated guidance on drug shortage prevention plansThe European Medicines Agency has published a revised guideline aimed at helping marketing authorisation holders develop and keep drug shortage prevention plans for their products. The new guidanc…