regulatory affairs

November Regulatory Updates
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Medical Devices: ISO 10993-1:2025 finally released, 6th edition of the standard on Biological risk evaluation...
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Neutraceuticals regulation, how it differ from country to country and how to be compliant
Nutraceuticals Regulations: Understanding EU, USA and International Compliance
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Nowadays, nutraceuticals are becoming popular for their potential health benefits, yet their regulatory identity remains...
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PMC novità linee guida pubblicità
Novità PMC sulle linee guida per la pubblicità: cosa c’è da sapere
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Il 21 Luglio 2025 è stata pubblicata una nuova linea guida che va a regolare...
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October Regulatory Updates
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Medical Devices: FDA Draft Guidance on Quality Management System Regulation (QMSR) The FDA has published...
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CBD as Novel Food: Last Call to Have Your Say!
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EFSA is changing its mind with regard to the safety of CBD food products following...
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September Regulatory Updates
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Medical Devices: Consultation Open: EU seeks to simplify MDR and IVDR Frameworks The European Commission...
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Trump administration to allow medications to be purchased directly from pharma companies
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What is the TrumpRx platform? The Trump administration has been considering launching a government-operated website,...
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The GRAS Act: Transforming United States’ Food Safety Landscape
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On August 12, 2025, Representative Frank Pallone (D-NJ) introduced the Grocery Reform and Safety Act...
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August Regulatory Updates
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Medical Devices: European Commission Confirms Continued Use of Titanium Dioxide in Medicinal Products Background On...
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Chemsafe’s Summer Reading Recommendations 2025
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With the warmth of the summer sun shining down, there is no better time to...
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