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    FDA’s Steps Toward a new Review Framework for Medical Devices Using Artificial Intelligence Algorithms

    This article provides a high-level overview of FDA’s proposed framework specifically tailored to promote the development of medical devices using artificial intelligence algorithms; it is not intended to provide a detailed explanation of the proposal, which is very technical.   Introduction   On 2 April 2019, the Food and Drug Administration (FDA) issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to pro...
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    FDA Citizen Petitions: What They Can and Cannot Do

    This article provides an overview of the US Food and Drug Administration's (FDA's) citizen petition process as it relates to the drug industry and highlights several key issues raised by this process. The authors focus on 505(q) and discuss its potential implications. Introduction FDA regulations provide for a citizen petition process enabling the public to request FDA to take or refrain from taking a certain action. The citizen petition process also is used to bring ot...