Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says
Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.
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In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.
Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.
With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.