Category: Regulatory – Blog

Four Ways to Reduce Regulatory Risk Using RIM

If you asked a regulatory colleague about the purpose of a Regulatory Information Management (RIM) system, they might say to provide replacement for spreadsheets, consolidate regulatory information in one place, or to enable tracking and management of approvals.  They might even mention compliance.  I would

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FDA News: FDA Updates Various eCTD Documents

Recently, the FDA updated a number of documents related to eCTD.  These changes are summarized in the eCTD Submission Standards document, which provides a consolidated change history and links to supporting documents. Support for Modeling and Simulation.   This is an interesting area which is evolving

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FDA Removes Two-Way Communication from eCTD 4.0

FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was issued without comment, and includes two components: CTD v4.0 Technical Conformance Guide (PDF) FDA eCTD v4.0 Module 1 Implementation Package (ZIP) The

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Managing post-approval CMC changes with RIM & QMS

Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes.  A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs and regulatory operations. A diverse set of independent or loosely integrated systems are involved: Enterprise

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FDA Eliminates the need for Paper Device Submissions

Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in electronic format. Because a medical device premarket submission in electronic format is easily reproducible, the

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