Pfiz­er, Gilead and oth­ers seek clar­i­fi­ca­tions on tri­al de­signs out­lined in FDA's UC and Crohn's draft guid­ance

Phar­mas act to make sure their voic­es get heard — and be­fore the FDA it’s no dif­fer­ent. Es­pe­cial­ly when it re­lates to draft guid­ance.

Mul­ti­ple Big Phar­ma com­pa­nies sought tweaks from the FDA on draft guid­ance re­lat­ed to the de­vel­op­ment of new drugs for ul­cer­a­tive col­i­tis and Crohn’s dis­ease. Those two in­di­ca­tions are key ther­a­peu­tic ar­eas for sev­er­al of the ma­jor phar­ma play­ers.

The drafts ex­plain the FDA’s cur­rent think­ing around how to de­sign clin­i­cal tri­als for these two dis­ease ar­eas, in­clud­ing rec­om­men­da­tions for tri­al pop­u­la­tion, tri­al de­sign, and ef­fi­ca­cy and safe­ty con­sid­er­a­tions.

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