FDA Defends Lab Test Oversight Before Critical Lawmakers

By Jeff Overley (September 9, 2014, 1:21 PM EDT) -- A high-ranking U.S. Food and Drug Administration official pushed back hard Tuesday on Capitol Hill against criticism of agency plans to regulate sophisticated lab tests, saying there's clear legal authority for oversight and that ensuring accurate diagnoses is crucial to personalized medicine's future.

Jeffrey E. Shuren, director of the FDA's Center for Devices and Radiological Health, mounted the defense after encountering pointed questioning at a House Energy and Commerce Committee hearing about looming requirements for so-called laboratory developed tests to sometimes seek agency approval.

A recurring complaint from Republican lawmakers — echoed later in the hearing by representatives of clinical laboratories...

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!