Ep. 106 - China's C-suite Hears FDA, Plus AACR, ARPA-H
BioCentury This Week
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Do You Want to See China Only Data for Pty One Applications?
The committee voted 14 to one to require additional trials that would demonstrate applicability to patients and medical care before they would approve it. The message really resonated all of them, regardless of their programme. Almost all of them said they would be increasing their communications, seeking more meetings with fda. They expect e m a to take a similar position on china only trials.
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