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- FDA’s new CBER and CDER heads back adaptive framework for rare disease therapiesNewly appointed permanent directors of FDA’s CBER and CDER, Karim Mikhail and Michael Davis, indicated they will continue the agency’s push for an adaptive regulatory framework aimed at rare diseas…
- Par Health recalls two lots of dexmedetomidine infusion due to particulate contaminationPar Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…