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Simplify the complex with customized blog posts on life sciences regulation from AgencyIQ. We bring daily updates and analysis on the things that matter to you—helping you get smarter about regulation on the horizon and your next course of action.

FDA publishes second round of material safety reports for medical devices
FDA publishes second round of material safety reports for medical devices

Jan 18, 2022

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FDA wants help with real-world data drug submission standards
FDA wants help with real-world data drug submission standards

Jan 11, 2022

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Major FDA reorganization adds structures to support gene therapy, diagnostics, AdPromo and more
Major FDA reorganization adds structures to support gene therapy, diagnostics, AdPromo and more

Jan 04, 2022

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New bipartisan legislation would create a Neuroscience Center of Excellence
New bipartisan legislation would create a Neuroscience Center of Excellence

Dec 21, 2021

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Regulation
FDA reveals plans for several new regulations in latest Unified Agenda

Dec 13, 2021

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Consequences of not paying user fees discussed in 2 new MAPPs

Dec 08, 2021

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Generic drug data show steady year-over-year trends in first-cycle approvals, refuse-to-receive decisions

Nov 12, 2021

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FDA issues initial draft guidance on leveraging clinical and billing real-world data sources for regulatory use

Oct 01, 2021

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FDA releases BsUFA III Commitment Letter outlining proposed changes to biosimilar development pathway

Sep 21, 2021

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