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    2017 Regulatory Intelligence Tools Update: Drugs

    When tasked with something new or different in regulatory, sometimes the hardest challenge is knowing where to find the information. This article provides an abundance of tools, links and places to start your journey of regulatory information discovery. Regulatory intelligenceis "the act of gathering and analyzing publicly available regulatory information." This includes communicating the implications of that information and monitoring the current regulatory environmen...
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    Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada

    This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities. Introduction Analysis of regulatory precedent, locating regulatory "evidence" that can assist in predicting regulatory outcomes, is an essential activity for a biopharma regulatory intelligence department. ...