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Latest From Ramsey Baghdadi
Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.
MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?
Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go in approving new entrants to a market with widespread historic off-label use and CV risks.
US FDA’s revised draft guidance spelling out its policy on 'refuse-to-file' decisions differs little in substance compared to predecessor issued in 1993. But difference in style is telling sign of the times.