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    How FDA is Using REMS to Help Manage the Opioid Crisis

    This article discusses how FDA has been using the Risk Evaluation and Mitigation Strategies (REMS) program to try to limit opioid misuse and abuse by restricting the availability of these important drugs to patients who really need them to treat intractable pain. For several opioids, FDA has urged manufacturers to work together to create shared REMS to expedite management and assessment of the REMS requirements. Introduction During the first decades of the 21st century,...
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    Book Review: Eclectic Science and Regulatory Compliance: Stories for the Curious

    The following is an insightful review of a compilation of essays featuring new, somewhat obscure information about science, regulatory and healthcare products. There can be no more delightful way to learn a few extra regulatory concepts than by reading a book written by Max Sherman. Eclectic Science and Regulatory Compliance: Stories for the Curious is Sherman's second book of essays on regulatory science. A few years ago, when I read his earlier volume of essays, ...
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    FDA’s Botanical Drug Policy Continues to Develop

    As recently as 150 years ago, most pharmaceuticals were obtained directly from plants; now, most are synthetic. However, in the past 20 years, the US Food and Drug Administration (FDA) has seen a future for botanical drug products. The agency began work on a guidance on botanical drugs in 1996, 1 and issued Guidance for Industry: Botanical Drug Products 2 and an associated manual of policies and procedures (MaPP) in 2004. In 2006, FDA approved the New Drug Applicatio...