Under the draft guidance, the FDA could fine researchers who submit false or incomplete data to ClinicalTrials.gov, a clinical trials database maintained by the U.S. National Library of Medicine. The guidance covers researchers submitting data to the FDA regarding drug, biological and device products who violate requirements mandated under the Federal Food, Drug, and Cosmetic Act.
The draft guidance, developed by three centers at the FDA, follows periodic reports of hospitals failing to submit required data to the database, according to Politico‘s Morning eHealth newsletter.
To view the FDA’s draft guidance, click here. The FDA is accepting comments on the draft guidance through Nov. 20.
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