FDA fi­nal­izes guid­ance on adap­tive tri­al de­signs

The FDA last week fi­nal­ized guid­ance on adap­tive clin­i­cal tri­al de­signs for drugs and bi­o­log­ics.

The 33-page guid­ance, which fi­nal­izes a draft ver­sion re­leased for com­ment in Sep­tem­ber 2018 and re­places an ear­li­er guid­ance from 2010, sets out the FDA’s rec­om­men­da­tions on adap­tive tri­al de­sign prin­ci­ples and the in­for­ma­tion the FDA will re­view from adap­tive stud­ies sub­mit­ted as part of in­ves­ti­ga­tion­al new drug ap­pli­ca­tions (INDs), new drug ap­pli­ca­tions (NDAs), bi­o­log­ics li­cense ap­pli­ca­tions (BLAs) and sup­ple­men­tal ap­pli­ca­tions.

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