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Drug Regulation

Product Monitoring FDA Leadership Indecopi Actions ANSM Quality Control CDSCO Approval European Medicines Agency Central Drug Standards Control Organisation Biogen MHRA European Commission Approval

FDA Names Tracy Beth Høeg Acting CDER Director as OTC Drugs Chief Is Reassigned

The shuffle follows Richard Pazdur’s rapid exit, extending a year of churn at the drug regulator.

EMA Panel Backs Higher-Dose Spinraza for 5q SMA