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Wednesday
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9 September, 2026 |
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Karthik Musunuri, a Pennsylvania-based biotech entrepreneur, met with senior FDA officials yesterday to discuss all things related to speeding up the early processes around starting clinical trials, potentially allowing the US to be more competitive with China and Australia when it comes to Phase 1 trials. He noted that the agency is focused on potentially shifting its data standard requirements to make them easier, and potentially allowing toxicology studies to rely on one species of animal, rather than the current requirement of two. "They are still concerned on China - how to maybe make this pathway only eligible for American companies somehow so it’s not inundated with foreign sponsors," he added. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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by Max Bayer
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The FDA has made permanent the leaders of CDER and CBER, stabilizing key agency posts as a new commissioner awaits confirmation. The decision was announced... | |
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by Zachary Brennan
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The FDA's major shift in September 2025 to begin publishing drug rejection letters is still an evolving process. But moving forward, the US agency should... | |
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by Max Bayer
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Top FDA leaders are doubling down on clinical trial oversight measures to ensure that research data generated outside the US are adequate, as lawmakers and... | |
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by Anna Brown
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AstraZeneca clinched an FDA accelerated approval for its oral SERD in certain breast cancer patients Friday, even after a negative votefrom the agency’s advisory... | |
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Worldwide made. Thanks for reading.
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