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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…
- Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launchCompass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…