FDA GDF 2025 - Inactive Ingredients in Generic Drug Applications: Building a Global Understanding
Автор: The FDA Learning Cache
Загружено: 2025-06-12
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Details and supporting materials: https://fdalearn.com/GDF2025
At the 2025 Generic Drugs Forum, Pamela Dorsey presents on building a global framework for assessing inactive ingredients in generic drug applications. She outlines the FDA’s current approach to evaluating inactive ingredients—including maximum daily exposure (MDE) calculations and population-specific considerations—then compares these practices to those of international regulatory agencies within the generic drug cluster. Through a detailed poll of cluster members, she identifies both commonalities and divergences in assessment methods, such as database use, MDE calculation standards, and evaluation of ingredient grades and context of use. Two case studies underscore the importance of rigorous evaluation, particularly for vulnerable populations. Dorsey concludes by emphasizing the value of international collaboration in aligning regulatory standards and reducing industry burden while maintaining drug safety.
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