Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN Exclusives

More »

For full access to this article login to GEN Select now.

Mar 26, 2014

FDA and LDTs—What’s Next?

The Administration is claiming power over laboratory-developed tests. However, the lab industry disagrees.

FDA and LDTs—What’s Next?

The FDA, for over twenty years, has asserted that it has authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. [© inkaone - Fotolia.com]

  • Laboratory-developed tests (LDTs) continue to proliferate. Companies are regularly announcing the introduction of new LDTs, and these tests are playing a more important role ...

Not registered yet? Please fill out the form below and enjoy complimentary access to this and an exclusive collection of premium content and personalization features as a GEN Select insider. Learn More.

Get GEN Select Access Now

    • Do not put any letters or characters here if you are not a spy program.
    •  


Be sure to take the GEN Poll

Drug Price Hikes

Novum Pharma recently raised the price of an acne cream by over 3,900% in less than a year-and-a-half and Mylan increased price of EpiPen from $100 to $608 . Do you think pharmaceutical companies need to be subjected to price controls?

More »