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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Inside US FDA’s Return To In-Person Meetings
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.
US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests
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.
Rare Disease Expertise On FDA Advisory Committees Gains Capitol Hill Attention
With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.