From Vigilare Biopharma: The recent PRAC meeting (2-5 June 2025) underscores the relentless pace of pharmacovigilance evolution. From gene therapy safety to AI integration and refined risk management for established classes, the demands on sponsors
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TGA Seeks Feedback to Modernize Clinical Trial & Pharmacovigilance Australia’s Therapeutic Goods Administration (TGA) is revising its clinical trial and pharmacovigilance guidelines to align with global benchmarks—a move poised to reshape research and drug safety practices.
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EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation
Read MoreIntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This
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Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions
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New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz
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DCTs are not a fad, but a trend that is transforming clinical research and patient care. By leveraging technology to make trials more accessible
Read MoreWelcome to the latest edition of our Pharma News and Regulatory News Updates, where we bring you the most significant developments and breakthroughs in the pharmaceutical industry and the latest updates from regulatory agencies worldwide.
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