In a first, FDA warns a re­searcher for fail­ing to sub­mit da­ta 3 years af­ter tri­al com­ple­tion

For the first time ever, the FDA has threat­ened an in­di­vid­ual clin­i­cal tri­al in­ves­ti­ga­tor with a fine af­ter he failed to pub­lish tri­al da­ta on a gov­ern­ment data­base. The warn­ing is part of a wider at­tempt to hold re­searchers and com­pa­nies ac­count­able for sub­mit­ting tri­al re­sults af­ter tri­als fin­ish.

An­drey Petrikovets, a sur­geon from Los An­ge­les, ran a study on pain drug reg­i­mens fol­low­ing vagi­nal pelvic floor re­con­struc­tive surgery, but failed to pub­lish re­sults on time, the FDA said in a warn­ing let­ter post­ed this week.

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