FDA de­clines to is­sue fines for non­com­pli­ant tri­al re­port­ing

The FDA said it won’t im­pose fines or take greater en­force­ment ac­tion against clin­i­cal tri­al spon­sors when they fail to prop­er­ly re­port tri­al in­for­ma­tion to the gov­ern­ment. The agency said it will in­stead con­tin­ue to urge vol­un­tary com­pli­ance, ac­cord­ing to a cit­i­zen pe­ti­tion re­sponse filed Wednes­day.

The 30-page pe­ti­tion, filed last Feb­ru­ary by the Uni­ver­si­ties Al­lied for Es­sen­tial Med­i­cines, as­serts that the FDA’s en­force­ment of clin­i­cal tri­al re­port­ing has been min­i­mal and lacks fo­cus.

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