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Historic Output Of Disease-Specific Guidances Is Among Gottlieb's Legacies At US FDA

 
• By Michael Cipriano

A Pink Sheet analysis illustrates how the outgoing commissioner enhanced FDA's ability to facilitate the further development of innovative drugs. 

At the beginning of his tenure, now-outgoing US FDA Commissioner Scott Gottlieb said the agency will be prioritizing the development of disease-specific guidance documents as a way to facilitate innovative drug development. (Also see "FDA's Gottlieb Pushing 'Seamless' Clinical Trials For Faster Development" - Pink Sheet, 12 September, 2017.) He certainly looks to have kept that promise.

A Pink Sheet analysis of FDA guidance documents shows that FDA issued 36 disease-specific guidances during Gottlieb's nearly 22 months as head of the agency, including 23 draft guidances and 13 final

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