eBook: Waiting for Guidelines, Will FDA take the reins of laboratory-developed tests?

Wading into the regulatory territory occupied by LDTs is like stepping into a murky, slow-flowing river. It’s difficult to see where the next step lies, and at any minute, you might stub your toe on an unseen obstacle. There’s no way of knowing how deep it gets. And the bottom might drop off at any minute.

A new set of FDA regulations, covering a field the agency has chosen not to supervise in the past, could be a danger on both sides. It’s new regulation, at a time when even the financial meltdown couldn’t inspire much additional oversight. And as many a lab, test developer, consultant and FDA lawyer could say--and some have--it’s the kind of regulation that threatens to stifle innovation. Meaning: The new test that could revolutionize your loved ones’ treatment, that might save their lives, could be swallowed up by government red tape.

Table of Contents:

  • An altered FDA Mindset
  • Developers Face an Uncertain LDT Path
  • No Shortage of Ideas
  • The Sequenom Saga
  • State of New York LDTs
  • Waiting for FDA Guidance
  • Future innovations

By providing deep dives on timely industry issues, Fierce eBooks are valuable educational tools. They are designed to be easily read online - but also are formatted so you can print them out and take them with you. Fierce eBooks are assembled like a magazine, read the whole thing cover-to-cover, or pick and choose the articles that interest you most. Either way, they're a great one-stop resource.

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