Proposed FDA Drug Software Rules Strict On Pharma Cos.

By Albert Cacozza, Kellie Combs, Joshua Oyster and Rebecca Williams (December 10, 2018, 2:55 PM EST) -- On Nov. 20, 2018, the U.S. Food and Drug Administration issued a Federal Register notice seeking public comment on the FDA's proposed framework for regulating prescription drug-use-related software, or PDURS, the agency's latest move in modernizing the regulatory requirements for digital health technologies. Under the proposed framework, which the FDA intends to develop into a draft and, ultimately, a final guidance document, the FDA would regulate the output of PDURS — software "disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor's prescription drugs (including biological drug products)" — as drug labeling. As such, the software output would be subject to the FDA's regulations for FDA-required labeling or promotional labeling, as applicable....

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