Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
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A draft guidance document by the US FDA that tackles medical device cybersecurity will likely be issued in the next several months, says Linda Ricci, a health scientist for the agency’s Office of Device Evaluation. Check out her comments on cybersecurity here.
Phase Ib data at ASH look competitive with new pivotal trial results for Bristol/bluebird’s leading BCMA CAR-T bb2121. The Phase II portion of the CARTITUDE-1 study for JNJ-4528 is fully enrolled.