75% of Generic Drug Applications Delayed by Freedom to Operate Issues: Stability Testing Strategies Highlighted

A recent study reveals that Freedom to Operate (FTO) issues are a significant cause of delays in the approval of generic drug applications. Specifically, three-quarters of generic drug applications experience delays related to FTO concerns. To address these challenges, a new blog post is available that highlights key considerations for generic drug stability testing and strategies to mitigate potential delays. The DrugPatentWatch.com blog post, found at https://www.drugpatentwatch.com/blog/conducting-a-biopharmaceutical-freedom-to-operate-fto-analysis-key-considerations-for-generic-drug-stability-testing/, focuses on conducting a biopharmaceutical FTO analysis. The information in the blog aims to inform biopharmaceutical companies about how to avoid delays. The issues are primarily relevant to generic drug companies.

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Date: April 15, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後