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FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals

Simon Osuji by Simon Osuji
February 19, 2026
in Technology
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FDA outlines new review pathway for drugs treating ultra-rare diseases
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In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

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