Generic Reviews Getting NDA-Style Communication Enhancements

Despite its unprecedented workload, FDA's Office of Generic Drugs is getting more chatty at work: the office is changing its policy to allow for phone communications with applicants

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New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Gohibic (vilobelimab), InflaRx’s treatment for adult patients with SARS-CoV-2-induced acute respiratory distress syndrome.

Robert Califf Stabilized US FDA, His Departure May Signal A Coming Storm

 

The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its future are high.

US FDA Commissioner Califf’s Farewell Visit To Capitol Hill

 

Robert Califf’s final appearance on Capitol Hill as US FDA commissioner, a 5 December Senate hearing focused on the agency’s food and nutrition functions, was an appropriate coda to his tenure and preview of things to come under the Trump Administration.