Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
News
11 August 2020
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...
Insights
Registered Content
03 March 2020
A new ruling by the U.S. District Court for the Southern District of New York could require companies to make public a decade of clinical trial results for products that have been approved...
Insights
Registered Content
14 February 2019
Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy...
News
05 November 2018
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful...
Insights
Registered Content
25 September 2018
On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."
Publications
21 August 2017
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and...
Hogan Lovells Publications
27 June 2017
On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 —...
Publications
17 April 2017
On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results...
