In September 2016, the US Department of Health and Human Services (DHHS) issued the final rule for ‘Clinical Trials Registration and Results Information Submission (42 CFR Part 11)’ expanding on the 2007 US Food and Drug Administration (FDA) Amendments Act (FDAAA) Section 801. It requires (amongst other things) submission to ClinicalTrials.gov of results information for trials of unapproved products and submission of the study protocol and statistical analysis plan at the same time as posting results information.

Just 1 month later, in Europe, we saw public availability of all clinical study reports for two drugs newly approved by the European Medicine Agency (EMA) under Policy 0070.

Download our thoughts on the background to greater data disclosure and its implications for the biopharmaceutical/vaccine/device industry.

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