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.
You may also be interested in...
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.
Cidara’s Rezafungin: Dosing Convenience Warrants Antifungal’s Limited Approval, US FDA Panel Says
Use should be targeted for patients with candidemia/invasive candidiasis who require longer-term therapy and for whom daily intravenous administration with currently approved echinocandins is problematic, Antimicrobial Drugs Advisory Committee says.
US FDA Implementing Hybrid Work Policy In January
Agency employees will have on-site, telework and remote possibilities, but options will depend on the center, office and job duties.