HHS now requires public posting of a decade of clinical trial results that were previously exempted

Lexology August 11, 2020
Hogan Lovells

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have been approved by the Food and Drug Administration (FDA). In a surprising move, the Department of Health and Human Services (HHS) has now signaled it does not intend to appeal the ruling, and has made changes to the results submission requirements of ClinicalTrials.gov in accord with the District Court’s decision. There has been relatively little fanfare surrounding these changes given their significance – to date, no notice in the Federal Register has been published announcing the adoption of these new requirements...

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