FDA issues rare notice of noncompliance for not reporting clinical trial results

In a rare move, the FDA is­sued a no­tice of non­com­pli­ance to an on­col­o­gy com­pa­ny for fail­ing to sub­mit clin­i­cal da­ta on its treat­ment for be­nign pro­sta­t­ic hy­per­pla­sia to a fed­er­al data­base.

Un­der the Food and Drug Ad­min­is­tra­tion Amend­ments Act of 2007, spon­sors are re­quired to sub­mit cer­tain re­sults from clin­i­cal tri­als to Clin­i­cal­Tri­als.gov, gen­er­al­ly no lat­er than one year af­ter com­ple­tion of the tri­al. They can be grant­ed an ex­ten­sion if they sub­mit a re­quest for a de­lay in post­ing the da­ta, though the re­quest must be sub­mit­ted by a cer­tain dead­line.

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