Development In-Vitro Licensing Reagent 
pharmaphorum
SEPTEMBER 29, 2022
Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. The FDA’s General Approach to Regulating mHealth Products.
FDA Law Blog
AUGUST 3, 2022
Mullen — Happy Birthday Laboratory Developed Tests (LDTs). Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. As with any “child” they’ve matured and developed as they’ve grown into adulthood. By Jeffrey N.
FDA Law Blog
NOVEMBER 1, 2023
Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).
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