FDA chief Scott Got­tlieb promis­es to stream­line drug de­vel­op­ment path­way for bio­phar­ma

FDA Com­mis­sion­er Scott Got­tlieb on Tues­day told a House Ap­pro­pri­a­tions sub­com­mit­tee that the agency plans to “sharply in­crease” its re­lease of dis­ease-fo­cused guid­ance doc­u­ments to help drug­mak­ers de­vel­op new treat­ments.

“Among some of the many ar­eas we’re work­ing on right now are new guid­ance to lay out mod­ern cri­te­ria for the de­vel­op­ment of drugs tar­get­ed to ul­cer­a­tive col­i­tis; rare pe­di­atric can­cers; pe­di­atric HIV; and se­ri­ous, life-threat­en­ing and non-can­cer blood dis­or­ders like aplas­tic ane­mia,” ac­cord­ing to Got­tlieb’s writ­ten tes­ti­mo­ny on the 2019 bud­get.

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