It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTs
FDA Law Blog
AUGUST 3, 2022
Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. 92P-0405 (Aug.
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