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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.

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

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

Court ruling would require public posting of a decade of clinical trial results that HHS regulation had exempted
Registered Content

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

ICMJE requires registrations for clinical trials to include disclosure of data sharing plan
Registered Content

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

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

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

Crackdown coming? Draft guidance suggests FDA is looking more closely at clinical trial disclosures
Registered Content

On Friday, September 21, the Food and Drug Administration (FDA) published a draft guidance titled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank."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

There'll be some changes made: President signs prescription drug and biologic user fee reauthorization act Pharmaceutical Client Alert

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

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical investigations

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 —...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

Just One More Day Compliance Deadline for New ClinicalTrials gov Regulations is Tuesday April 18 2017 Pharma/Biotech Alert

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...

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