US FDA Makes Flexibility Look Routine In TB Drug Review, But Not Everyone Is Pleased

The most remarkable aspect of the positive advisory committee for pretomanid is how routine FDA’s flexibility in the face of unmet need is starting to feel – but there are some dissenting voices that merit attention. 

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The US FDA is making regulatory flexibility look like a snap.

The most remarkable aspect of the US Food & Drug Administration’s approach to the review of pretomanid, a potential new treatment for highly resistant strains of tuberculosis submitted by the TB Alliance, is how routine it seemed.

Pretomanid has a Qualified Infectious Disease Product designation, signaling its special status in the context of the campaign to address microbial resistance. Like so many recent FDA approvals, the drug is focused on a significant unmet need in a small patient population, at least in the US where multi-drug resistant TB is extremely rare

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