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Educational Video—All You Need to Know About 505 (b)(2), but Were Afraid to Ask
Автор: Altasciences
Загружено: 2025-06-26
Просмотров: 69
Описание: This presentation explores the 505(b)(2) regulatory pathway, which allows drug developers to leverage existing data to streamline preclinical requirements. Ideal for repurposing existing active ingredients, it offers cost and time savings, with potential for market exclusivity. The speaker, a preclinical expert, highlights key considerations, including study requirements and the value of a pre-IND meeting with the FDA.
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