What To Watch As EU Clinical Trial Compliance Changes

By Sonia Nath, Elisabethann Wright and Natasha Leskovsek (July 13, 2021, 6:47 PM EDT) -- Earlier this year, industry became more intimately familiar with the clinical trials reporting requirements in the U.S. when, on April 27, the U.S. Food and Drug Administration sent a notice of noncompliance to Acceleron Pharma Inc. identifying the company's failure to submit study results from a November 2017 trial that tested the efficacy of dalantercept and axitinib, proposed treatments for renal cell carcinoma.

As sponsors and principal investigators seek to learn from the Acceleron example, it is important for industry to consider reporting requirements not just in the U.S., but also for the European Union given the Clinical Trials Regulation, which,...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!