US FDA Commissioner Scott Gottlieb is laying the groundwork for public disclosure of complete response letters (CRLs) driven by safety or other concerns with "significant public health value" – a move that could at least partially lift the veil on why drug applications fail to gain the regulator's nod.
The agency is trying to identify a "manageable" subset of CRLs in which approval was denied for reasons that can help inform clinical practice and the public health, Gottlieb said...
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