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Earlier this year, the FDA granted approvals for two noteworthy gene therapy products. In one case, the product received accelerated approval with a review time of approximately 9 months and included an advisory committee meeting during the review cycle. The other product received full approval after a much longer review time that included a complete response letter and resubmission of the application.
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The safety of patients receiving drug or biologic products is paramount in both the investigational and post-marketing settings. Preparing routine required safety updates can be an arduous and time-consuming process with different data lock points (DLPs), Reference Safety Information (RSI), and reporting timeframes for clinical studies and post-marketing reports. This month, I thought I would take a step back and talk about periodic safety reporting in both the investigational and post-marketing setting and how one can streamline the process. This blog will focus on routine required reports, not expedited reporting.
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As many of us are well aware, while single arm trials (SATs) historically have been accepted by the US FDA as primary evidence of efficacy for marketing approval in the setting of accelerated approval (AA) of new oncology agents/indications, their acceptance in other therapeutic areas including rare diseases has been more selective.
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Draft Guidance - Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
This guidance issued in March 2023 has been the subject of much talk. While in my opinion, it does not provide any new thoughts on the part of FDA regarding how they handle requests for approval using the accelerated approval (AA) pathway, it does put in writing the policies they have implemented in recent reviews and communications with sponsors.
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