FDA looks on while major U.S. institutions violate medical research rules

peter.suber's bookmarks 2021-11-22


"The FDA has issued warnings to only a handful of the companies and institutions with the worst track records of violating a key clinical trial disclosure law, a new report finds.


Out of 51 large US-based companies and institutions that have failed to make five or more clinical trial results public, only three have been contacted by the U.S. drug regulator, and only one has received a final warning, FDA enforcement data show.


Failing to rapidly make clinical trial results public on the American trial registry harms patients because it slows down medical progress, leaves gaps in the medical evidence base, and wastes public funds. ..."



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Open Access Tracking Project (OATP) » peter.suber's bookmarks


oa.new oa.usa oa.medicine oa.clinical_trials oa.data oa.usa.fda oa.compliance oa.obstacles oa.harm oa.universities oa.industry oa.hei oa.pharma

Date tagged:

11/22/2021, 09:49

Date published:

11/22/2021, 04:49