Got­tlieb lays out re­al world ev­i­dence pri­or­i­ties for 2019 with an eye on dig­i­tal tools

Stress­ing the need for speed and ef­fi­cien­cy, FDA Com­mis­sion­er Scott Got­tlieb on Mon­day of­fered a look at FDA’s plans around re­al-world da­ta (RWD) and re­al-world ev­i­dence (RWE) in 2019.

The speech at the Bi­par­ti­san Pol­i­cy Cen­ter built off a frame­work, re­leased in De­cem­ber, that sought to be­gin the con­ver­sa­tion on how RWD and RWE can sup­port changes to la­bel­ing, in­clud­ing adding or mod­i­fy­ing an in­di­ca­tion, changes in dose, dose reg­i­men or route of ad­min­is­tra­tion; chang­ing or adding new pop­u­la­tions; or the ad­di­tion of com­par­a­tive ef­fec­tive­ness or safe­ty in­for­ma­tion.

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