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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She is as polarizing as she is powerful, but whether you think Janet Woodcock is drug development’s hero or public health’s enemy, there’s no denying she dramatically transformed the US FDA over her 35-year career.
US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons calculus for the patients described in a drug's label. While not a new policy perse, it is one the agency seems to have only grudgingly employed in the past.
Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?