As the US Food & Drug Administration moves back to in-person advisory committees after four years of pandemic-induced virtual meetings, stakeholders are likely to see different approaches in how the panels are utilized by the drug and biologics product centers and the Oncology Center of Excellence.
While there is agreement on some big-picture issues – such as the need to return to in-person meetings – the Center for Drug Evaluation & Research, Center for Biologics Evaluation...
Key Takeaways
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Most of FDA’s efforts to revamp adcomms has taken place behind the scenes, with now-Principal Deputy Commissioner Namandjé Bumpus heading the effort.
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