Pharma

New Regulatory Framework for Fermentation and Semi-Synthetic Antibiotics by FDA
FDA sets Impurities Specifications: New Draft Guidance on Antibiotics
by Gabriele Pincitore|09/06/2026|Blog, Pharma
In April 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance titled...
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Extractable and Leachables material composition and supply chain for ICH Q3E compliance
ICH Q3E: E&L risks with Material Variability and Supply Chain
by Gabriele Pincitore|31/03/2026|Blog, Pharma
ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
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Permitted Daily Exposure
Permitted Daily Exposure within EMA and ICH Framework
by Gabriele Pincitore|24/02/2026|Blog, Pharma
Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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Watching DNA Repair in Real Time: A Revolutionary New Sensor
by Gabriele Pincitore|09/12/2025|Blog, Pharma
Watching DNA Repair in Real Time: A Revolutionary New Sensor Our DNA is under constant...
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Trump administration to allow medications to be purchased directly from pharma companies
by Gabriele Pincitore|30/09/2025|Blog, Pharma
What is the TrumpRx platform? The Trump administration has been considering launching a government-operated website,...
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Breaking Barriers: Including Pregnant and Breastfeeding Individuals in Clinical Trials
by Gabriele Pincitore|08/07/2025|Blog, Pharma
Clinical trials have long shaped the future of medicine. But for decades, one vital population...
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Understanding the Reflection Paper on the Qualification of Non-Mutagenic Impurities: A Regulatory Perspective
by Gabriele Pincitore|12/05/2025|Blog, Pharma
Introduction In the complex world of pharmaceutical development, ensuring drug safety and efficacy is paramount....
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FDA Issues Draft Guidance on AI in Drugs and Devices
by Gabriele Pincitore|18/03/2025|Blog, Pharma
FDA Releases Draft Guidance on AI in Drug and Medical Device Development The U.S. Food...
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Machine Learning in Early Prediction of Metabolism of Drugs
by Gabriele Pincitore|25/11/2024|Blog, Pharma
Marta Lettieri, Virginia Carlucci and Marco Rodda have contributed to the latest edition of Computational...
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How Mario Draghi’s Vision for European Competitiveness Could Transform the Pharma Industry
by Gabriele Pincitore|08/10/2024|Blog, Pharma
The pharmaceutical industry stands at the crossroads of significant transformation as Europe rethinks its global...
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