What’s New for Biologics

What’s New for Biologics

• BK180306 - MacoPress Smart Smarter and DMS Plus 
  Posted: 1/31/2019
• Fast Track Designation Request Performance 
  Updated: 1/30/2019
• Malaria gene activity findings could form basis of improved test for monitoring disease spread 
  Posted: 1/30/2019
• BK180258 - Vista Information System 
  Posted: 1/30/2019

Recently Added

• Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot L67530 through January 31, 2020 
  Posted: 2/1/2019
• BK180306 - MacoPress Smart Smarter and DMS Plus 
  Posted: 1/31/2019
• Fast Track Designation Request Performance 
  Updated: 1/30/2019
• Malaria gene activity findings could form basis of improved test for monitoring disease spread 
  Posted: 1/30/2019
• BK180258 - Vista Information System 
  Posted: 1/30/2019
• BK180280 - DG Gel Essential Control 
  Posted: 1/29/2019
• eSubmitter Application History 
  Updated: 1/29/2019
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Information on TICE BCG
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Update on RECOMBIVAX HB - Dialysis formulation
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Update on RECOMBIVAX HB - Pediatric/Adolescent formulation
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Update on RECOMBIVAX HB - Adult formulation
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Update on SHINGRIX
• CBER-Regulated Products: Current Shortages 
  Posted: 1/8/2019; Information on Cuvitru