We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
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A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.