Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Two studies failed to demonstrate that Eylea was non-inferior to laser treatment. Agency says compared to the expected natural history, there is a ‘clear beneficial effect’ of Eylea which also maintains peripheral vision. Advisory committee to discuss how to convey findings in label.
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.