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Life Sciences › Disclosure Requirements › Clinical Trials

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Health Care Compliance Association (HCCA) on

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Arnall Golden Gregory LLP

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Arnall Golden Gregory LLP on

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

ArentFox Schiff on

Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

Butler Snow LLP on

From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

King & Spalding on

Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Orrick, Herrington & Sutcliffe LLP

Managing and Maintaining Clinical Trial Disclosure for Publicly Traded Life Sciences Companies

Orrick, Herrington & Sutcliffe LLP on

One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

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 published by the International Committee of Medical...more

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