Two years and more than 900 comments to the docket later, the National Institutes of Health (NIH) has published the final rule for clinical trial registration at clinicaltrials.gov, declaring that the rule will go into force on Jan. 18, 2017. Of some concern to drug and device makers is that the agency has indicated it intends to apply the terms of the rule retroactively, putting sponsors on the hook for updating incomplete clinical study entries within 90 days of the effective date of the rule if they want to avoid a fine of $10,000 per day per violation. Read More
