Implications of FDA’s Decision to Issue Fines for Failing to Submit Clinical Trial Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

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Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no longer apply to the United Kingdom ( ...

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