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RELATED INSIGHTS
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Rare But Not Forgotten: Opportunities in Rare Disease Drug Development
This article was co-written by Samantha Zappia, Principal Consultant, SK Regulatory Solutions. The World Orphan Drug Congress (WODC) brings together industry leaders working to advance orphan and rare disease drug development in one place for a unique three-day event. Many attendees arrive with the goal of meeting other players in the industry, learning from successes […]
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Success Planning for an Original NDA / BLA Submission
This comprehensive webinar offers an insightful exploration into the intricate landscape of New Drug Applications (NDAs) and Biologics License Applications (BLAs), elucidating the pivotal regulatory procedures imperative for pharmaceutical companies seeking approval for novel drugs and biologics. Its primary objective is to equip participants with the requisite knowledge and resources essential for navigating the intricate […]
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Bringing In Vitro Diagnostics to Market with Real-World Evidence
In vitro diagnostic (IVD) devices are a unique type of medical device. Although they meet the definition of a medical device, they are not intended to treat a disease or condition. Rather, they are the instruments or reagents that analyze samples taken from patients. IVDs are less invasive than traditional medical devices, but still present […]
