Firms Hope To Adapt COVID Vaccine Trial Design, FDA Communication Approaches To Other Diseases
Moderna has adopted more inclusionary enrollment criteria and real-time epidemiology monitoring for its RSV vaccine program, while Pfizer is expanding its internal ‘Lightspeed’ approach. US FDA is considering how to extend the fast, frequent and informal interactions.
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Califf Sees Potential For New Emergency Use Authorities But Concerned About Industry Follow Through
The FDA Commissioner suggests the US may need to fix economic incentives that keep industry from completing studies of drugs granted speedier paths to market before opening those pathways to new disease areas, but expressed particular interest in thinking about how EUAs could be used for non-opioid pain treatments.
Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs
CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
New breakthrough therapy designations bolster Pfizer’s maternal RSV vaccine and Bavarian Nordic’s older adult program, while Sanofi/AstraZeneca prepare to submit nirsevimab BLA and GSK deals with fallout of safety-driven Phase III trial pause.