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GMP News

PFAS in the Healthcare Sector: Innovations for a Sustainable Future in Europe

The EU is advancing research to reduce PFAS in the healthcare sector in order to minimize environmental and health-related risks. A new Europe Horizon project aims to reduce emissions, develop safe alternatives and make the European healthcare sector more sustainable.

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New FDA-Guidance for Industry draft on AI

AI (Artificial Intelligence) is becoming an increasingly important topic in the pharmaceutical sector. On 7 January 2025, the FDA published a first draft of a Guidance for Industry 'Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products'. The comment period ends on 7 April 2025. What is the FDA's focus here?

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EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence

The European Medicines Agency (EMA) has published a new document entitled "Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms".

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