Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows
CDER Director tells FDA appeals board that Duchenne muscular dystrophy development could suffer if Sarepta's drug not approved.
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Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?
In whistleblower complaint, Rick Bright claims FDA Commissioner Hahn advocated for distributing hydroxychloroquine to pharmacies across the US, a departure from the approved emergency use authorization. Bright's complaint paints CDER Director Woodcock in a favorable light, saying she helped avoid an expanded access IND protocol for the potential coronavirus treatment.
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).