FDA has accepted for filing Vericel’s Biologics License Application for MACI™ (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended to treat adult symptomatic knee cartilage defects. FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of 1/3/17, and does not plan to convene an advisory committee meeting to discuss the application.
FDA has accepted for filing Vericel's Biologics License Application for MACI™ (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended to treat adult symptomatic knee cartilage defects. FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of 1/3/17, and does not plan to...
FDA has accepted for filing Vericel’s Biologics License Application for MACI™ (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended to treat adult symptomatic knee cartilage defects. FDA provided a PDUFA (Prescription Drug User Fee Act) goal date of 1/3/17, and does not plan to convene an advisory committee meeting to discuss the application.
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