FDA sends 2nd non­com­pli­ance no­tice for com­pa­ny fail­ing to post tri­al re­sults as crack­down ramps up

The FDA is slow­ly but sure­ly con­tin­u­ing its crack­down on drug­mak­ers that fail to post their clin­i­cal tri­al re­sults to a gov­ern­ment data­base in a time­ly man­ner, this week go­ing af­ter Geor­gia-based Ac­cuitis, which de­vel­ops new treat­ments for skin dis­or­ders.

Al­though the agency has pre­vi­ous­ly out­lined how it may take en­force­ment ac­tion and as­sess $10,000 per day fines against com­pa­nies that fail to re­port their re­sults, the agency has on­ly sent two let­ters of non­com­pli­ance so far, and no fines have been is­sued to date.

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