FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

By Kristin McDougall, Workstream Lead, Transparency & Disclosure Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s ...

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EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

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The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

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Updated ClinicalTrials.gov Quality Control Review Criteria

On June 27, 2018, ClinicalTrials.gov posted updated support documents reflecting the current quality control (QC) review process, including review of data elements added by the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) for protocol registration and results information. ClinicalTrials.gov QC Review Process The ClinicalTrials.gov QC review proc ...

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