FDA+ roundup: Fi­nal guid­ance on the fastest on­col­o­gy drug ap­provals; Re­mote in­spec­tions fail to take off

The FDA on Tues­day fi­nal­ized guid­ance from Ju­ly 2022 on the speedy can­cer drug re­views that, for the last six years, the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence has been us­ing as part of its Re­al-Time On­col­o­gy Re­view (RTOR) to speed these faster eval­u­a­tions of ap­pli­ca­tions.

The guid­ance ex­plains how spon­sors can ap­ply to RTOR, what to sub­mit if ac­cept­ed, and how the re­al-time re­views are dif­fer­ent from rolling re­views in that rolling re­views re­quire com­plete sec­tions (e.g., the com­plete clin­i­cal mod­ule) to be sub­mit­ted pri­or to a com­plete ap­pli­ca­tion sub­mis­sion.

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