FDA guid­ance ma­chine churns out 8 new doc­u­ments in less than a week

As the FDA’s ur­gency around pan­dem­ic-re­lat­ed ac­tiv­i­ties be­gins to re­cede, the agency has been on a tear over the past week in re­leas­ing new drug-re­lat­ed guid­ance doc­u­ments, with 8 new ones, in­clud­ing 3 from the ICH on E2B(R3) and oth­ers on ul­cer­a­tive col­i­tis (UC), Crohn’s dis­ease, and us­ing ctD­NA as a bio­mark­er in can­cer clin­i­cal tri­als.

The fi­nal ICH doc­u­ments in­clude a 159-page guid­ance on da­ta el­e­ments and mes­sage spec­i­fi­ca­tions, joint­ly de­vel­oped by the ICH E2B(R3) and M2 ex­pert work­ing groups, a re­gion­al im­ple­men­ta­tion guide, as well as an ap­pen­dix on the elec­tron­ic trans­mis­sion of in­di­vid­ual case safe­ty re­ports (IC­SRs).

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