What’s New for Biologics

What’s New for Biologics

• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (PDF - 219KB)
  Updated: 2/15/2019
• Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry (PDF - 194KB)
  Updated: 2/15/2019

Recently Added

• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (PDF - 219KB) 
  Updated: 2/15/2019
• Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry (PDF - 194KB) 
  Updated: 2/15/2019
• BK180286 - ALBAcyte IgG Sensitized Red Blood Cells II 
  Posted: 2/11/2019
• 22nd US-Japan Cellular and Gene Therapy Conference 
  Posted: 2/11/2019
• Pathogen Reduction Technologies for Blood Safety; Public Workshop 
  Updated: 2/8/2019
• Quantitation of AAV-Based Gene Therapy Products 
  Updated: 2/8/2019
• CBER Vacancy: Director, Division of Epidemiology - Title 38(F) Supervisory Physician (GP-0602-15) 
  Posted: 2/7/2019
• Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS) (PDF - 1.5MB) 
  Updated: 2/7/2019
• February 4, 2019 Approval Letter - Fluzone Quadrivalent -Sourthern Hemisphere (PDF - 33KB) 
  Posted: 2/5/2019
• Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year 
  Posted: 2/5/2019; Updated as of 2/1/2019
• Complete List of Licensed Products and Establishments 
  Posted: 2/4/2019; Updated as of 1/31/2019
• Complete List of Currently Approved NDA and ANDA Application Submissions (PDF - 31KB) 
  Posted: 2/4/2019; Updated as of 1/31/2019
• Complete List of Currently Approved Premarket Applications (PMAs) (PDF - 37KB) 
  Posted: 2/4/2019; Updated as of 1/31/2019
• Complete List of Substantially Equivalent 510(k) Device Applications (PDF - 697KB) 
  Posted: 2/4/2019; Updated as of 1/31/2019
• 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